CN111759889B - Hemostatic composition containing chitin and aerosol thereof - Google Patents

Hemostatic composition containing chitin and aerosol thereof Download PDF

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Publication number
CN111759889B
CN111759889B CN202010747752.XA CN202010747752A CN111759889B CN 111759889 B CN111759889 B CN 111759889B CN 202010747752 A CN202010747752 A CN 202010747752A CN 111759889 B CN111759889 B CN 111759889B
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extract
chrysanthemum
plantain
water
emulsion
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CN111759889A (en
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张建广
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Shandong Guangyuyuan Environmental Protection Technology Co ltd
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Shandong Guangyuyuan Environmental Protection Technology Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/287—Chrysanthemum, e.g. daisy
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716—Glucans
    • A61K31/722—Chitin, chitosan
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/68—Plantaginaceae (Plantain Family)
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • 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
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • 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 discloses a hemostatic composition containing chitin and aerosol thereof. Specifically, the invention provides a pharmaceutical composition, which is an emulsion, wherein the emulsion comprises: (A) The water phase comprises chitin, sodium hydroxide, carbonamide, an extract and water, wherein the extract is a water extract of chrysanthemum, plantain and laurel leaf; (B) An oil phase comprising palm oil, castor oil and stearic acid; and (C) an emulsifier, wherein the emulsifier comprises octyl phenol polyoxyethylene ether. The pharmaceutical composition can effectively stop bleeding at a bleeding wound, promote wound healing and diminish inflammation, thereby effectively reducing pain of a patient caused by bleeding.

Description

Hemostatic composition containing chitin and aerosol thereof
Technical Field
The invention relates to the field of medicines, in particular to a hemostatic composition containing chitin and aerosol thereof.
Background
The rapid hemostasis of wounds is a great difficulty, particularly in field activities, the wounds often cannot be timely and effectively treated in clinics or hospitals after bleeding, the hemostasis speed is low, the blood loss is high, a large amount of inflammatory factors are often accumulated at the wounds to cause inflammation, pus appears in serious patients, and the serious patients can cause great pain if the patients cannot be timely treated.
However, the existing rapid hemostatic material often has the defects of low hemostatic and wound healing promoting speed, incapability of effectively diminishing inflammation, suppurating and high price and the like, so that hemostasis, healing promotion and inflammation diminishing cannot be rapidly realized, and pain is caused to patients.
Therefore, there is a need in the art to develop a hemostatic material that has a rapid hemostatic and healing promoting speed and a good anti-inflammatory effect, so as to effectively reduce the pain caused by bleeding.
Disclosure of Invention
The invention aims to provide a pharmaceutical composition with rapid hemostasis and healing promotion and good anti-inflammatory effect, so that pain caused by bleeding can be effectively reduced.
In a first aspect of the present invention, there is provided a pharmaceutical composition which is an emulsion comprising:
(A) The water phase comprises chitin, sodium hydroxide, carbonamide, an extract and water, wherein the extract is a water extract of chrysanthemum, plantain and laurel leaf;
(B) An oil phase comprising palm oil, castor oil and stearic acid;
(C) And the emulsifying agent comprises octyl phenol polyoxyethylene ether.
Preferably, the extract is an aqueous extract of a mixed medicinal material of chrysanthemum, plantain herb and laurel leaf.
Preferably, the composition is an emulsion.
Preferably, the aqueous phase further comprises a wetting agent.
Preferably, the wetting agent comprises one or more of glycerol, propylene glycol and polyethylene glycol.
Preferably, the emulsion is an oil-in-water emulsion.
Preferably, the water is distilled water.
Preferably, the extract is a dry extract.
Preferably, the extract is a dry extract.
Preferably, the extract is a water-soluble dry extract.
Preferably, the octylphenol polyoxyethylene ether comprises octylphenol polyoxyethylene ether OP-10.
Preferably, the weight ratio of the chrysanthemum to the plantain to the laurel leaf is (1-5): (3-7): (0.5-4), preferably (2-4): (4-6): (1-3).
Preferably, the weight ratio of the chrysanthemum to the plantain is (1-5): (3-7), preferably (2-4): (4-6).
Preferably, the weight ratio of the chrysanthemum to the laurel leaf is (1-5): (0.5-4), preferably (2-4): (1-3).
Preferably, the chitin is 10-30 parts by weight, preferably 15-25 parts by weight, preferably 17-23 parts by weight.
Preferably, the sodium hydroxide is 2-20 parts by weight, preferably 5-15 parts by weight, preferably 8-12 parts by weight.
Preferably, the weight parts of the said carbonamide are 1 to 10 weight parts, preferably 2 to 8 weight parts, preferably 4 to 6 weight parts.
Preferably, the extract is 15-35 parts by weight, preferably 20-30 parts by weight, more preferably 22-28 parts by weight.
Preferably, the water is 500 to 600 parts by weight, preferably 540 to 580 parts by weight, preferably 550 to 570 parts by weight.
Preferably, the palm oil is 100 to 200 parts by weight, preferably 120 to 180 parts by weight, preferably 140 to 160 parts by weight.
Preferably, the castor oil is 80-160 parts by weight, preferably 100-140 parts by weight, preferably 110-130 parts by weight.
Preferably, the weight parts of stearic acid are 40-80 weight parts, preferably 50-70 weight parts, preferably 55-65 weight parts.
Preferably, the wetting agent (e.g., glycerol) is present in an amount of 20 to 40 parts by weight, preferably 25 to 35 parts by weight, more preferably 27 to 33 parts by weight.
Preferably, the octyl phenol polyoxyethylene ether is 10 to 30 parts by weight, preferably 15 to 25 parts by weight, more preferably 18 to 22 parts by weight.
Preferably, the parts by weight are in grams (g).
Preferably, the oil phase further comprises artemisinin.
Preferably, the artemisinin is 5-15 parts by weight, preferably 8-12 parts by weight.
Preferably, the aqueous phase is present in an amount of 60-70% (w/w), preferably 63-70% (w/w), based on the total weight of the composition.
Preferably, the oil phase is present in an amount of 25 to 40% (w/w), preferably 30 to 35% (w/w), based on the total weight of the composition.
Preferably, the emulsifier is present in an amount of 1-8% (w/w), preferably 1-5% (w/w), based on the total weight of the composition.
Preferably, the sum of the amounts of the aqueous phase, the oil phase and the emulsifier is 100% (w/w), calculated on the total weight of the composition.
Preferably, the extract is prepared by the following method:
mixing flos Chrysanthemi, herba plantaginis and laurel leaf, pulverizing, extracting with water, filtering, concentrating and drying the filtrate to obtain the extract.
Preferably, the extract is prepared by the following method:
mixing flos Chrysanthemi, herba plantaginis and laurel leaf, pulverizing, adding 4-6 times of water, extracting at 65-75deg.C for 8-14 hr, filtering, concentrating and drying the filtrate to obtain the extract.
Preferably, the drying is reduced pressure concentration drying.
Preferably, the prescription of the pharmaceutical composition comprises:
Figure BDA0002606859020000031
Figure BDA0002606859020000041
the extract is an aqueous extract of mixed medicinal materials of chrysanthemum, plantain and laurel leaf, wherein the weight ratio of the chrysanthemum to the plantain to the laurel leaf is (1-5): (3-7): (0.5-4).
Preferably, the prescription of the pharmaceutical composition comprises:
prescription composition Parts by weight of
Palm oil 120-180
Castor oil 100-140
Stearic acid 50-70
Octyl phenol polyoxyethylene ether OP-10 15-25
Extract of plant 20-30
Sodium hydroxide 5-15
Carbonamides 2-8
Chitin 15-25
Glycerol 25-35
Water and its preparation method 540-580
The extract is an aqueous extract of mixed medicinal materials of chrysanthemum, plantain and laurel leaf, wherein the weight ratio of the chrysanthemum to the plantain to the laurel leaf is (2-4): (4-6): (1-3).
Preferably, the prescription of the pharmaceutical composition comprises:
prescription composition Parts by weight of
Palm oil 140-160
Castor oil 110-130
Stearic acid 55-65
Octyl phenol polyoxyethylene ether OP-10 18-22
Extract of plant 22-28
Sodium hydroxide 8-12
Carbonamides 4-6
Chitin 17-23
Glycerol 27-33
Water and its preparation method 550-570
The extract is an aqueous extract of mixed medicinal materials of chrysanthemum, plantain and laurel leaf, wherein the weight ratio of the chrysanthemum to the plantain to the laurel leaf is (2-4): (4-6): (1-3).
Preferably, the prescription of the pharmaceutical composition comprises:
prescription composition Parts by weight of
Optionally artemisinin 5-15
Palm oil 120-180
Castor oil 100-140
Stearic acid 50-70
Octyl phenol polyoxyethylene ether OP-10 15-25
Extract of plant 20-30
Sodium hydroxide 5-15
Carbonamides 2-8
Chitin 15-25
Glycerol 25-35
Water and its preparation method 540-580
The extract is an aqueous extract of mixed medicinal materials of chrysanthemum, plantain and laurel leaf, wherein the weight ratio of the chrysanthemum to the plantain to the laurel leaf is (2-4): (4-6): (1-3).
Preferably, the prescription of the pharmaceutical composition comprises:
prescription composition Parts by weight of
Optionally artemisinin 8-12
Palm oil 140-160
Castor oil 110-130
Stearic acid 55-65
Octyl phenol polyoxyethylene ether OP-10 18-22
Extract of plant 22-28
Sodium hydroxide 8-12
Carbonamides 4-6
Chitin 17-23
Glycerol 27-33
Water and its preparation method 550-570
The extract is an aqueous extract of mixed medicinal materials of chrysanthemum, plantain and laurel leaf, wherein the weight ratio of the chrysanthemum to the plantain to the laurel leaf is (2-4): (4-6): (1-3).
Preferably, the average particle size of the emulsion is 60-90nm, preferably 60-90nm.
Preferably, the composition is in the form of an emulsion.
Preferably, the composition is in the form of an external preparation or an aerosol.
In a second aspect of the present invention there is provided a method of preparing a pharmaceutical composition according to the first aspect of the present invention, said method comprising the steps of:
(1) Adding sodium hydroxide and carbonamide with the prescription amount into water with the prescription amount of 1/3-1/5, adding chitin with the prescription amount, fully stirring at low temperature, adding octyl phenol polyoxyethylene ether with the prescription amount, an extract, an optional wetting agent and the rest amount of water, and fully stirring at 65-75 ℃ to obtain an aqueous phase A;
(2) Mixing palm oil, castor oil, stearic acid and optional artemisinin with a prescription amount, heating to 65-75 ℃, stirring, mixing and dissolving to obtain oily B phase;
(3) Slowly injecting the oily B phase into the aqueous A phase under stirring, continuously stirring for 4-6min, homogenizing for 4-6min at 8000-12000 r with a homogenizer, and emulsifying to obtain the final product.
In a third aspect the present invention provides an aerosol comprising a pharmaceutical composition according to the first aspect of the present invention and a propellant.
Preferably, the propellant comprises HFC-134A.
Preferably, the propellant is used in an amount of 5-15% (w/w), preferably 8-12% (w/w).
Preferably, the aerosol further comprises an aerosol canister, the composition and propellant being located in the aerosol canister.
In a fourth aspect of the invention there is provided a method of preparing an aerosol according to the third aspect of the invention, the method comprising the steps of:
filling the pharmaceutical composition according to the first aspect of the invention into an aerosol can, adding a valve to seal the can, filling a propellant, and then mounting a can lid to obtain the aerosol.
In a fifth aspect, the present invention provides the use of a pharmaceutical composition according to the first aspect of the present invention for the preparation of a pharmaceutical formulation for haemostasis, promotion of wound healing and/or anti-inflammatory.
Preferably, the wound comprises a skin wound.
Preferably, the wound comprises a skin wound that trails below the dermis.
Preferably, the inflammation comprises inflammation at a wound.
Preferably, the anti-inflammatory is performed by reducing inflammatory factors.
Preferably, the inflammatory factor includes IL-1β, IL-6 and/or TNF- α.
It is understood that within the scope of the present invention, the above-described technical features of the present invention and technical features specifically described below (e.g., in the examples) may be combined with each other to constitute new or preferred technical solutions.
Detailed Description
The invention develops a pharmaceutical composition, which is an emulsion, wherein the emulsion comprises a water phase, an oil phase and an emulsifying agent, the water phase comprises chitin, sodium hydroxide, carbonamide, an extract and water, and the extract is an aqueous extract of chrysanthemum, plantain and laurel leaf; the oil phase comprises palm oil, castor oil and stearic acid, and the emulsifier comprises octyl phenol polyoxyethylene ether. Experimental researches show that the emulsion composition disclosed by the invention can effectively perform rapid hemostasis on bleeding wounds, promote wound healing and diminish inflammation, so that pain of patients caused by bleeding is effectively reduced.
Terminology
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
As used herein, the terms "comprising," including, "and" containing "are used interchangeably to include not only the open definition, but also the semi-closed, and closed definition, including" consisting of … …, "" consisting essentially of … ….
As used herein, chrysanthemum is the dried head-like inflorescence of the aster chrysanthemum Chrysanthemum morifolium ramat.
As used herein, plantain is a dried or fresh whole herb of plantain Plantago asiatica l of plantain family or plantago asiatica willd.
As used herein, laurel leaf is a leaf of Laurus nobilis l.
Pharmaceutical composition and preparation method thereof
The present invention provides a pharmaceutical composition capable of rapid hemostasis, promotion of wound healing and anti-inflammatory of bleeding wounds, typically in the form of an emulsion comprising:
(A) The water phase comprises chitin, sodium hydroxide, carbonamide, an extract and water, wherein the extract is a water extract of chrysanthemum, plantain and laurel leaf;
(B) An oil phase comprising palm oil, castor oil and stearic acid; and
(C) And the emulsifying agent comprises octyl phenol polyoxyethylene ether.
In a preferred embodiment of the invention, the aqueous phase further comprises a wetting agent. Typically, the wetting agent includes (but is not limited to) one or more of glycerin, propylene glycol, polyethylene glycol.
In another preferred mode of the invention, in the extract in the water phase, the weight ratio of the chrysanthemum, the plantain and the laurel leaf is (1-5): (3-7): (0.5-4), preferably (2-4): (4-6): (1-3).
Typically, the formulation of the composition comprises:
prescription composition Parts by weight of
Palm oil 100-200
Castor oil 80-160
Stearic acid 40-80
Octyl phenol polyoxyethylene ether OP-10 10-30
Extract of plant 15-35
Sodium hydroxide 2-20
Carbonamides 1-10
Chitin 10-30
Glycerol 20-40
Water and its preparation method 500-600
The extract is an aqueous extract of mixed medicinal materials of chrysanthemum, plantain and laurel leaf, wherein the weight ratio of the chrysanthemum to the plantain to the laurel leaf is (1-5): (3-7): (0.5-4).
Preferably, the formulation of the composition comprises:
Figure BDA0002606859020000081
Figure BDA0002606859020000091
the extract is an aqueous extract of mixed medicinal materials of chrysanthemum, plantain and laurel leaf, wherein the weight ratio of the chrysanthemum to the plantain to the laurel leaf is (2-4): (4-6): (1-3).
Preferably, the formulation of the composition comprises:
prescription composition Parts by weight of
Palm oil 140-160
Castor oil 110-130
Stearic acid 55-65
Octyl phenol polyoxyethylene ether OP-10 18-22
Extract of plant 22-28
Sodium hydroxide 8-12
Carbonamides 4-6
Chitin 17-23
Glycerol 27-33
Water and its preparation method 550-570
The extract is an aqueous extract of mixed medicinal materials of chrysanthemum, plantain and laurel leaf, wherein the weight ratio of the chrysanthemum to the plantain to the laurel leaf is (2-4): (4-6): (1-3).
Preferably, the prescription of the pharmaceutical composition comprises:
Figure BDA0002606859020000092
Figure BDA0002606859020000101
the extract is an aqueous extract of mixed medicinal materials of chrysanthemum, plantain and laurel leaf, wherein the weight ratio of the chrysanthemum to the plantain to the laurel leaf is (2-4): (4-6): (1-3).
The invention also provides a method for preparing the pharmaceutical composition, which comprises the following steps:
(1) Adding sodium hydroxide and carbonamide with the prescription amount into water with the prescription amount of 1/3-1/5, adding chitin with the prescription amount, fully stirring at low temperature, adding octyl phenol polyoxyethylene ether with the prescription amount, an extract, an optional wetting agent and the rest amount of water, and fully stirring at 65-75 ℃ to obtain an aqueous phase A;
(2) Mixing palm oil, castor oil and stearic acid with the prescribed amount, heating to 65-75 ℃, stirring, mixing and dissolving to obtain an oily B phase;
(3) Slowly injecting the oily B phase into the aqueous A phase under stirring, continuously stirring for 4-6min, homogenizing for 4-6min at 8000-12000 r with a homogenizer, and emulsifying to obtain the final product.
Aerosol and preparation method thereof
The present invention also provides an aerosol comprising a pharmaceutical composition according to the invention and a propellant.
Preferably, the propellant comprises HFC-134A.
Preferably, the aerosol further comprises an aerosol canister, the composition and propellant being located in the aerosol canister.
The present aspect also provides a method of preparing an aerosol according to the present invention, the method comprising the steps of:
the pharmaceutical composition disclosed by the invention is filled into an aerosol can, a valve is added for sealing, then a propellant is filled, and a can cover is arranged to prepare the aerosol.
Use of the same
The invention also provides the application of the pharmaceutical composition in preparing a pharmaceutical preparation for stopping bleeding, promoting wound healing and/or resisting inflammation.
In a preferred embodiment, the wound comprises a skin wound.
In another preferred embodiment, the inflammation comprises inflammation at a wound site.
Preferably, the anti-inflammatory is performed by reducing inflammatory factors.
Preferably, the inflammatory factor includes (but is not limited to) IL-1β, IL-6 and/or TNF- α.
The main technical effects of the invention include:
1. the invention develops an emulsion composition, which can effectively stop bleeding at a bleeding wound, promote wound healing and diminish inflammation, thereby effectively reducing pain of a patient caused by bleeding.
2. The emulsion composition can be prepared into aerosol, and can be conveniently, simply and quickly sprayed to a wound in a spraying mode, so that the pain of a patient caused by bleeding is quickly reduced, and the aerosol is convenient to carry.
The invention will be further illustrated with reference to specific examples. It is to be understood that these examples are illustrative of the present invention and are not intended to limit the scope of the present invention.
Example 1
The preparation of the chitin-containing emulsion in this example is as follows:
preparing a water-soluble dry extract:
mixing and crushing 3 parts by weight of chrysanthemum, 5 parts by weight of plantain herb and 2 parts by weight of laurel leaf, adding 5 times of water, extracting for 12 hours at 70 ℃, filtering, concentrating and drying the filtrate under reduced pressure to obtain water-soluble dry extract.
The formulation of the emulsion of this example is shown in table 1:
table 1 prescription composition of emulsion
Figure BDA0002606859020000111
Figure BDA0002606859020000121
The preparation method comprises the following steps:
the emulsion of example 1 of the present invention was prepared in the same manner as follows:
(1) Adding the prescribed amount of sodium hydroxide and carbonamide into 1/4 of the prescribed amount of distilled water, adding the prescribed amount of chitin, fully stirring at low temperature, adding the prescribed amount of octyl phenol polyoxyethylene ether OP-10, water-soluble dry extract, glycerol and the rest amount of distilled water, and fully stirring at 70 ℃ to obtain an aqueous phase A;
(2) Mixing and heating palm oil, castor oil and stearic acid with the prescribed amount to 70 ℃, stirring, mixing and dissolving to obtain an oily B phase;
(3) Slowly injecting the oily B phase into the aqueous A phase under stirring, continuously stirring uniformly for 5min, homogenizing for 5min at 10000 revolutions with a homogenizer, and emulsifying to obtain the oil-in-water emulsion.
During the preparation, stearic acid forms sodium stearate and ammonium stearate in-water oil-in-water emulsifiers with sodium hydroxide and carbamide during mixing of the oil and water phases.
Particle size performance measurement:
the average particle size of the emulsion was 73.8.+ -. 6.9nm as measured by a Markov laser particle sizer.
Example 2
This embodiment is identical to embodiment 1, except that,
preparing a water-soluble dry extract:
mixing and crushing 7 parts by weight of chrysanthemum, 2 parts by weight of plantain herb and 1 part by weight of laurel leaf, adding 5 times of water, extracting for 12 hours at 70 ℃, filtering, concentrating and drying the filtrate under reduced pressure to obtain water-soluble dry extract.
The formulation of the emulsion is shown in table 2:
table 2 prescription composition of emulsion
Figure BDA0002606859020000122
Figure BDA0002606859020000131
Example 3
This example is identical to example 1, except that the formulation of the emulsion is as shown in Table 3:
table 3 prescription composition of emulsion
Figure BDA0002606859020000132
Example 4
This example is identical to example 1, except that the formulation of the emulsion is as shown in Table 4:
table 4 prescription composition of emulsion
Figure BDA0002606859020000133
Figure BDA0002606859020000141
Example 5
The embodiment provides an aerosol, the preparation method of which comprises the following steps:
the emulsion prepared in example 1 was filled into an aerosol can, and after valve sealing, sufficient HFC-134A propellant (propellant) was filled, and after plastic cap was installed, the aerosol was prepared.
Example 6
This example is identical to example 1, except that the formulation of the emulsion is as shown in Table 5:
table 5 prescription composition of emulsion
Figure BDA0002606859020000142
The preparation method comprises the following steps:
the emulsion of example 1 of the present invention was prepared in the same manner as follows:
(1) Adding the prescribed amount of sodium hydroxide and carbonamide into 1/4 of the prescribed amount of distilled water, adding the prescribed amount of chitin, fully stirring at low temperature, adding the prescribed amount of octyl phenol polyoxyethylene ether OP-10, water-soluble dry extract, glycerol and the rest amount of distilled water, and fully stirring at 70 ℃ to obtain an aqueous phase A;
(2) Mixing and heating the prescribed amount of artemisinin, palm oil, castor oil and stearic acid to 70 ℃, stirring, mixing and dissolving to obtain an oily B phase;
(3) Slowly injecting the oily B phase into the aqueous A phase under stirring, continuously stirring uniformly for 5min, homogenizing for 5min at 10000 revolutions with a homogenizer, and emulsifying to obtain the oil-in-water emulsion.
During the preparation, stearic acid forms sodium stearate and ammonium stearate in-water oil-in-water emulsifiers with sodium hydroxide and carbamide during mixing of the oil and water phases. The emulsion prepared in example 6 was filled into an aerosol can, and after valve sealing, sufficient HFC-134A propellant (propellant) was filled, and after plastic cap was installed, the aerosol was prepared.
Effect test
1. Hemostatic test
The hemostatic effect of the emulsions prepared in examples 1-4 of the present invention was examined by a rat tail-breaking experiment, and in a rat tail-breaking model, the hemostatic effect was evaluated by coagulation time.
Test sample: medical gauze respectively soaked in the emulsion and physiological saline prepared in the embodiment 1-4 of the invention is used as a test sample;
experimental method
Rats were randomly divided into 5 groups of 5 rats, after tail-breaking of each group, the tail-breaking sites were wrapped with medical gauze immersed in the emulsion and physiological saline solution prepared in examples 1 to 4 of the present invention, and the hemostatic time was recorded, and the results are shown in table 6:
table 6 hemostasis time (n=5)
Test group Hemostatic time (min)
Example 1 3.1±0.26
Example 2 6.1±0.59
Example 3 5.2±0.55
Example 4 4.7±0.43
Physiological saline 16.2±1.2
As can be seen from table 6, the emulsions prepared in examples 1 to 4 have excellent hemostatic effects compared to the blank physiological saline.
2. Experiment for promoting skin wound healing
Test sample: the emulsions prepared in examples 1-4 of the present invention.
The test method comprises the following steps: BALB/c mice were randomly divided into 4 groups of 5 mice each, four limbs of the BALB/c mice were fixed to a mouse plate, the head was allowed to shake, hairs of 2 identical areas on both sides of the back of each mouse were removed, skin was exposed, and then skin wounds, which were wound below dermis, of the same depth were made in the identical areas on both sides of the back of each mouse with a razor blade, respectively.
The skin wounds on one side of the back of the 4 groups of mice are respectively smeared with the same amount of the emulsion prepared in the embodiment 1-4 of the invention, physiological saline is smeared on the skin wounds on the other side of the back of the same mice to serve as self negative control, the skin wounds are smeared once every 3 hours, the time required by the skin healing of each mouse is recorded, and the improvement times of the skin wound healing efficiency of each mouse are calculated:
healing efficiency = time required for healing of physiological saline-coated skin wound/time required for healing of emulsion-coated skin wound.
Healing efficiency of skin wounds for each group as shown in table 7:
TABLE 7 fold improvement in skin wound healing efficiency
Test group Multiple times
Example 1 6.6±0.57
Example 2 4.1±0.34
Example 3 5.3±0.42
Example 4 4.9±0.51
As can be seen from table 7, the emulsions prepared in examples 1 to 4 have excellent skin wound healing promoting effects.
3. Anti-inflammatory experiment
Test sample: the emulsions prepared in examples 1-4 of the present invention.
The test method comprises the following steps: BALB/c mice were randomly divided into 4 groups of 5 mice each, four limbs of the BALB/c mice were fixed to a mouse plate, the head was allowed to shake, hairs of 2 identical areas on both sides of the back of each mouse were removed, skin was exposed, and then skin wounds, which were wound below dermis, of the same depth were made in the identical areas on both sides of the back of each mouse with a razor blade, respectively.
The skin wounds on one side of the back of the 4 groups of mice are respectively smeared with the same amount of emulsion prepared in the embodiment 1-4 of the invention, the skin wounds on the other side of the back of the same mice are smeared with normal saline as self negative control, the smears are smeared once every 2 hours, after 1 hour after the second smears are smeared, the emulsion on the two sides of the back of the same mice and the normal saline smeared hairless skin tissue are respectively homogenized, supernatant tissues are taken after centrifugation, protein quantification is carried out on each sample, and the expression levels of inflammatory factors IL-1 beta (interleukin 1 beta), IL-6 (interleukin 6) and TNF-alpha (tumor necrosis factor alpha) in the skin tissues are detected by an ELISA method (according to the operation description of a kit).
The reduction rate of inflammatory factors in the emulsion-applied hairless skin tissue compared to the normal saline-applied hairless skin (negative control) is shown in table 8:
TABLE 8 decrease rates of inflammatory factors IL-1 beta and IL-6, TNF-alpha (%)
Test group IL-1β IL-6 TNF-α
Example 1 87.9％ 84.8％ 86.5％
Example 2 79.6％ 75.7％ 73.1％
Example 3 42.8％ 38.9％ 36.8％
Example 4 38.5％ 36.5％ 34.9％
Remarks: reduction rate (%) = (content of normal saline-coated hairless skin inflammatory factor-content of inflammatory factor in emulsion-coated hairless skin tissue)/content of normal saline-coated hairless skin inflammatory factor in the same mouse.
As can be seen from table 8, the emulsions prepared in examples 1 to 4 were able to significantly treat inflammation at skin wounds, and it was found that palm oil and castor oil as oil phase components could synergistically enhance the therapeutic effect of the emulsions on inflammation.
The foregoing description is only of the preferred embodiments of the present application and is not intended to limit the same, but rather, various modifications and variations may be made by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application should be included in the protection scope of the present application.

Claims (6)

1. A pharmaceutical composition, wherein the pharmaceutical composition is an emulsion, the emulsion comprising:
(A) The water phase comprises chitin, sodium hydroxide, carbonamide, an extract and water, wherein the extract is a water extract of chrysanthemum, plantain and laurel leaf;
(B) An oil phase comprising palm oil, castor oil and stearic acid; and
(C) The emulsifier comprises octyl phenol polyoxyethylene ether;
the emulsion is an oil-in-water emulsion;
the prescription of the composition comprises:
Figure FDF0000021113550000011
the extract is an aqueous extract of mixed medicinal materials of chrysanthemum, plantain and laurel leaf, wherein the weight ratio of the chrysanthemum to the plantain to the laurel leaf is (1-5): (3-7): (0.5-4).
2. The pharmaceutical composition of claim 1, wherein the formulation of the composition comprises:
Figure FDF0000021113550000012
Figure FDF0000021113550000021
/>
the extract is an aqueous extract of mixed medicinal materials of chrysanthemum, plantain and laurel leaf, wherein the weight ratio of the chrysanthemum to the plantain to the laurel leaf is (2-4): (4-6): (1-3).
3. The pharmaceutical composition of claim 1, wherein the formulation of the composition comprises:
Figure FDF0000021113550000022
the extract is an aqueous extract of mixed medicinal materials of chrysanthemum, plantain and laurel leaf, wherein the weight ratio of the chrysanthemum to the plantain to the laurel leaf is (2-4): (4-6): (1-3).
4. An aerosol comprising the pharmaceutical composition of claim 1 and a propellant comprising HFC-134A;
the propellant is used in an amount of 5-15% (w/w), based on the total weight of the aerosol.
5. Use of a pharmaceutical composition according to claim 1 for the preparation of a pharmaceutical formulation for anti-inflammatory treatment.
6. The use according to claim 5, wherein the anti-inflammatory is by reducing inflammatory factors;
the inflammatory factors include IL-1 beta, IL-6 and/or TNF-alpha.
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Publication number Priority date Publication date Assignee Title
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CN106943328B (en) * 2017-04-10 2017-12-22 田徐腾越 A kind of oral cleaning formulations and preparation method thereof
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