CN111643536A - Nasal cavity medicine box and preparation method thereof - Google Patents
Nasal cavity medicine box and preparation method thereof Download PDFInfo
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- CN111643536A CN111643536A CN202010680778.7A CN202010680778A CN111643536A CN 111643536 A CN111643536 A CN 111643536A CN 202010680778 A CN202010680778 A CN 202010680778A CN 111643536 A CN111643536 A CN 111643536A
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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
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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
-
- 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
- A61K38/1808—Epidermal growth factor [EGF] urogastrone
-
- 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
- A61K47/26—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
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- 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
- A61K9/0043—Nose
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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
- A61K9/08—Solutions
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/02—Nasal agents, e.g. decongestants
-
- 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
Abstract
The application discloses a nasal drop, which comprises sodium hyaluronate, recombinant human epidermal growth factor and ectoin. The application also discloses a spray, a nasal cavity medicine box and a nasal cavity nursing method. The application nasal cavity medicine box, form by spray and nose drop two parts combination, the spray plays to moisturize in the nasal cavity, antibacterial while, can also soften nasal secretion, shrink the nasal mucosa, increase the area of contact of nose drop and nasal mucosa, make nose drop can alleviate the dry gall that arouses because of rhinitis fast in the nasal cavity, play long-term effect of moisturizing, promote the motion of nose cilia, repair impaired nasal mucosa fast, thereby alleviate nasal cavity uncomfortable symptoms such as nasal cavity dryness, nasal obstruction, the itch of nose, the running nose, nosebleed.
Description
Technical Field
The application relates to the technical field of nasal cavity medicines, in particular to a nasal cavity medicine box and a preparation method thereof.
Background
With the development of industrial process, the content of pollutants in the air is gradually increased, the air quality is deteriorated, and the environmental pollution is serious. In addition to seasonal changes, factors affecting human breathing in the air are increasing. The nasal cavity is the head end and portal of the respiratory tract. The vibrissa has a filtering effect on larger dust particles in the air; spongy blood sinuses are arranged under the mucosa of the nasal concha and can be used for regulating heat required by the nasal temperature; the nasal mucosa gland can secrete large amount of liquid for increasing the humidity of inhaled air and preventing the dryness of respiratory mucosa.
Rhinitis, an inflammatory disease of the nasal cavity, is inflammation of the mucous membrane of the nasal cavity caused by viruses, bacteria, allergens, various physicochemical factors and certain systemic diseases. Factors causing rhinitis include viral infection, genetic factors, susceptibility of nasal mucosa, introduction of antigenic substances, etc. Viral infections are the leading cause of rhinitis, which is mainly inhaled through the respiratory tract; inhalant allergens such as pollen, fungi, animal dander, house dust, etc. The main clinical symptoms of rhinitis are nose itch, dryness, nasal obstruction, watery nasal discharge, sense of smell decline, headache and dizziness, inappetence caused by rhinitis and the like, and even acute sinusitis, acute otitis media, acute pharyngitis, nasal vestibulitis and other infections are caused in severe cases, so that the health and the life quality of human beings are seriously influenced.
The treatment method of rhinitis mainly comprises drug treatment, operation treatment and nasal washing treatment. Corticosteroid and antihistamine are mostly adopted for drug therapy, and the second generation antihistamine drug has cardiotoxicity although the clinical effect is better, and has side effects such as weight gain of patients after taking the drug; glucocorticoids can cause systemic side effects under the condition of systemic administration, and are not recommended clinically; although nasal decongestants can relieve nasal congestion, the continuous use time cannot exceed one week, otherwise rhinitis medicamentosa or atrophic rhinitis can occur. The operation treatment is suitable for patients with severe nasal obstruction caused by anatomy and unsatisfactory drug treatment. The nasal wash belongs to a physical therapy, nasal sprays or nasal drops such as physiological seawater and physiological saline are mostly adopted on the market, the nasal wash has a single effect, only has the effect of washing the nasal cavity, cannot effectively and quickly repair damaged nasal mucosa and inhibit harmful bacteria in the nasal cavity, and the nasal cavity is sensitive and dry after being repeatedly washed for a long time. And due to the particularity of the nasal cavity structure, the active ingredients cannot be ideally distributed in the whole nasal cavity by single spraying or nasal dripping, so that the aims of effectively flushing the nasal cavity and repairing damaged nasal mucosa cannot be achieved.
Disclosure of Invention
The nasal cavity medicine box is formed by combining a spray agent and a nasal drop, the spray agent plays a role in moisturizing and bacteriostasis in the nasal cavity, can soften nasal secretion, shrink nasal mucosa, increase the contact area of the nasal drop and the nasal mucosa, and can quickly relieve dry swelling and pain caused by rhinitis in the nasal cavity, play a role in long-acting moisturizing, promote the movement of nasal cilia and quickly repair damaged nasal mucosa, so that nasal cavity discomfort symptoms such as nasal cavity dryness, nasal obstruction, nasal itching, rhinorrhea, epistaxis and the like are relieved.
The present application provides the following technical solutions.
1. A spray is characterized by comprising glycerol, propylene glycol, centipeda minima volatile oil and tween-80.
2. The spray according to item 1, characterized by comprising the following sprays in 100 parts by weight relative to the total weight:
glycerol: 1-5 parts;
0.2 to 2 portions of propylene glycol;
centipeda minima volatile oil: 0.08 to 1.5 parts;
tween-80: 0.1 to 1.5 portions.
3. The spray according to item 1, characterized by comprising the following sprays in 100 parts by weight relative to the total weight:
4. the spray according to any one of claims 1 to 3, wherein the preparation process of the centipeda minima volatile oil comprises the following steps: weighing centipeda minima, placing the centipeda minima in a flask, adding 30-50 times of purified water, shaking and mixing, connecting the flask with a volatile oil tester and a reflux condenser pipe, adding water at the upper end of a self-condensing pipe to enable the water to fill the scale part of the volatile oil tester and overflow to the flask, heating the flask until boiling, and keeping slight boiling for 4-5 hours to obtain the centipeda minima volatile oil.
5. A nasal drop is characterized by comprising sodium hyaluronate, recombinant human epidermal growth factor and ectoin.
6. The nasal drop according to item 5, characterized by comprising the following 100 parts by weight of nasal drops relative to the total weight:
sodium hyaluronate: 0.1 to 2.5 portions;
0.5 to 8 portions of ectoin;
0.0005 to 0.005 portion of recombinant human epidermal growth factor.
7. The nasal drop according to item 5, characterized by comprising the following 100 parts by weight of nasal drops relative to the total weight:
sodium hyaluronate: 0.33 to 1.65 portions;
1 to 5 portions of ectoin;
0.001 to 0.003 portion of recombinant human epidermal growth factor.
8. The nasal drop according to any one of claims 5 to 7, wherein the sodium hyaluronate comprises medium molecular sodium hyaluronate and small molecular sodium hyaluronate, and the molecular weight of the medium molecular sodium hyaluronate is 40 wDa-70 wDa, preferably 50 wDa-60 wDa; the molecular weight of the small-molecule sodium hyaluronate is 2500Da to 9500Da, preferably 3000Da to 8000 Da.
9. The nasal drop according to item 8, wherein the content of the medium-molecule sodium hyaluronate is 0.02 to 0.5 parts, preferably 0.03 to 0.15 parts, and the content of the small-molecule sodium hyaluronate is 0.08 to 2.0 parts, preferably 0.30 to 1.5 parts, relative to 100 parts by weight of the total nasal drop.
10. A nasal cavity medicine box is characterized by comprising two independent compartments, wherein spray and nasal drops are respectively stored in the two compartments.
11. The nasal kit of claim 10, wherein the spray comprises glycerin, propylene glycol, centipeda minima volatile oil, and tween-80.
12. The nasal kit according to item 11, characterized in that it comprises the following sprays in 100 parts by weight relative to the total weight:
glycerol: 1-5 parts;
0.2 to 2 portions of propylene glycol;
centipeda minima volatile oil: 0.08 to 1.5 parts;
tween-80: 0.1 to 1.5 portions.
13. The nasal kit according to item 11, characterized in that it comprises the following sprays in 100 parts by weight relative to the total weight:
14. the nasal cavity kit according to any one of claims 10 to 13, wherein the preparation process of the centipeda minima volatile oil comprises: weighing centipeda minima, placing the centipeda minima in a flask, adding 30-50 times of purified water, shaking and mixing, connecting the flask with a volatile oil tester and a reflux condenser pipe, adding water at the upper end of a self-condensing pipe to enable the water to fill the scale part of the volatile oil tester and overflow to the flask, heating the flask until boiling, and keeping slight boiling for 4-5 hours to obtain the centipeda minima volatile oil.
15. The nasal kit of claim 10, wherein the nasal drops comprise sodium hyaluronate, recombinant human epidermal growth factor, ectoin.
16. The nasal kit according to claim 15, characterized in that it comprises the following nasal drops in 100 parts by weight relative to the total weight:
sodium hyaluronate: 0.1 to 2.5 portions;
0.5 to 8 portions of ectoin;
0.0005 to 0.005 portion of recombinant human epidermal growth factor.
17. The nasal kit according to claim 15, characterized in that it comprises the following nasal drops in 100 parts by weight relative to the total weight:
sodium hyaluronate: 0.33 to 1.65 portions;
1 to 5 portions of ectoin;
0.001 to 0.003 portion of recombinant human epidermal growth factor.
18. The nasal kit according to any one of claims 15 to 17, wherein the sodium hyaluronate comprises medium molecular sodium hyaluronate and small molecular sodium hyaluronate, wherein the molecular weight of the medium molecular sodium hyaluronate is 40 wDa-70 wDa, preferably 50 wDa-60 wDa; the molecular weight of the small-molecule sodium hyaluronate is 2500Da to 9500Da, preferably 3000Da to 8000 Da.
19. The nasal kit according to claim 18, wherein the content of the medium-molecule sodium hyaluronate is 0.02 to 0.5 parts, preferably 0.03 to 0.15 parts, and the content of the small-molecule sodium hyaluronate is 0.08 to 2.0 parts, preferably 0.30 to 1.5 parts, relative to 100 parts by weight of the total nasal drop.
20. The nasal cavity kit according to claim 18, wherein when in use, the nasal drops are applied to the nasal cavity at an interval of 3-5 minutes after the spray is applied to the nasal cavity.
21. A nasal cavity nursing method is characterized in that the nasal drops of items 5-9 are applied into nasal cavities at intervals of 3-5 minutes after the spray of items 1-4 is applied to the nasal cavities.
22. Use of the spray of items 1 to 4 and the nasal drops of items 5 to 9 for preparing a nasal care solution.
The application provides a nasal cavity medicine box, this nasal cavity medicine box is formed by spray and nose drop two parts combination, compositions such as centipeda minima volatile oil, glycerine, propylene glycol in the spray play moisturizing, antibacterial in the nasal cavity, can also soften nasal secretion, contract the nasal mucosa, when using the nose drop, the contact area increase of compositions such as well as nasal cavity and nasal cavity of nose drop in the nose drop, prolong the active ingredient's active time, alleviate the dry gall that causes because of rhinitis fast, play the effect of long-term moisturizing, promote the ciliary motion of nose, repair impaired nasal mucosa fast, thereby alleviate nasal cavity uncomfortable symptoms such as nasal cavity dryness, nasal obstruction, nasal itching, watery nasal discharge, epistaxis.
According to the nasal drop, the small-molecular-weight sodium hyaluronate, the medium-molecular-weight sodium hyaluronate, the ectoin and the recombinant human epidermal growth factor are compounded, so that the nasal drop can be used for quickly repairing damaged nasal mucosa and improving epistaxis while resisting inflammation and improving nasal dryness caused by water shortage, and has a synergistic effect.
The centipeda minima volatile oil added in the application is used as a traditional Chinese medicine component for relieving nasal obstruction and nasal congestion, is safer than other formulas adopting toxic components such as magnolia flower, ephedra herb and the like, has no side effect on human bodies, and does not generate medication dependence.
Detailed Description
The following description of the exemplary embodiments of the present application, including various details of the embodiments of the present application to assist in understanding, should be taken as exemplary only. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the present application. Also, descriptions of well-known functions and constructions are omitted in the following description for clarity and conciseness.
Sodium hyaluronate is an acidic mucopolysaccharide, and can regulate permeability of blood vessel wall, regulate water electrolyte diffusion and transfer, and promote wound healing. Sodium hyaluronate has a special water retention effect, is a substance which is found to have the best moisture retention in nature at present, is called an ideal natural moisture retention factor, and is widely distributed in various parts of a human body. The small molecular weight sodium hyaluronate can be quickly absorbed by a human body to play a moisturizing and anti-inflammatory effect, and the medium molecular weight sodium hyaluronate can be attached to nasal mucosa to play a long-acting moisturizing effect, so that the treatment effect is prolonged.
The ectoin is derived from halophagous bacteria, has good anti-inflammatory repair effect, can structure free water in cells, continuously improves the moisture retention capacity of skin, is a very excellent humectant, and can effectively improve the immune protection capacity of skin cells, enhance the cell repair capacity and enable the skin to effectively resist the invasion of microorganisms and allergens.
The recombinant human epidermal growth factor is a multifunctional growth factor, can promote the synthesis of DNA, RNA and hydroxyproline in the process of repairing skin wound tissues, induce the reversion of differentiated mature epidermal cells into epidermal stem cells, accelerate the generation of wound granulation tissues and the proliferation of epithelial cells, can promote the repair of damaged nasal mucosa, shorten the healing time of the wound, relieve symptoms of epistaxis and the like.
Glycerol and propylene glycol are excellent moisturizing ingredients and are used to relieve nasal dryness.
The centipeda minima is a traditional Chinese medicine for relieving exterior syndrome, has the effects of expelling wind, dispelling cold, eliminating dampness, dredging nasal obstruction and the like, and is mainly used for treating acute and chronic rhinitis clinically at present, wherein the centipeda minima volatile oil is a main component for playing the pharmacological action.
Tween-80, also known as polysorbate-80, is widely used as an emulsifier for stable oil-in-water pharmaceutical emulsions. It can also be used as a solubilizer for various substances, including essential oils and oil-soluble vitamins, and as a wetting agent for oral or parenteral suspensions.
The application provides a spray, which comprises glycerin, propylene glycol, centipeda minima volatile oil and tween-80.
In the application, the spray comprises the following sprays in parts by weight relative to the total weight of 100:
glycerol: 1-5 parts;
0.2 to 2 portions of propylene glycol;
centipeda minima volatile oil: 0.08 to 1.5 parts;
tween-80: 0.1 to 1.5 portions.
In the application, the spray comprises the following sprays in parts by weight relative to the total weight of 100:
in the present application, the content of glycerin may be 1 part, 1.1 part, 1.2 parts, 1.3 parts, 1.4 parts, 1.5 parts, 1.6 parts, 1.7 parts, 1.8 parts, 1.9 parts, 2 parts, 2.1 parts, 2.2 parts, 2.3 parts, 2.4 parts, 2.5 parts, 2.6 parts, 2.7 parts, 2.8 parts, 2.9 parts, 3 parts, 3.1 parts, 3.2 parts, 3.3 parts, 3.4 parts, 3.5 parts, 3.6 parts, 3.7 parts, 3.8 parts, 3.9 parts, 4 parts, 4.1 parts, 4.2 parts, 4.3 parts, 4.4 parts, 4.5 parts, 4.6 parts, 4.7 parts, 4.8 parts, 4.9 parts, 5 parts, relative to 100 parts by weight of the total amount of the spray.
In the present application, the propylene glycol may be contained in an amount of 0.2 parts, 0.21 parts, 2.22 parts, 0.23 parts, 0.24 parts, 0.25 parts, 0.26 parts, 0.27 parts, 0.28 parts, 0.29 parts, 0.3 parts, 0.31 parts, 0.32 parts, 0.33 parts, 0.34 parts, 0.35 parts, 0.36 parts, 0.37 parts, 0.38 parts, 0.39 parts, 0.4 parts, 0.41 parts, 0.42 parts, 0.43 parts, 0.44 parts, 0.45 parts, 0.46 parts, 0.47 parts, 0.48 parts, 0.49 parts, 0.5 parts, 0.51 parts, 0.52 parts, 0.53 parts, 0.54 parts, 0.55 parts, 0.56 parts, 0.57 parts, 0.58 parts, 0.59 parts, 0.5 parts, 0.51 parts, 0.52 parts, 0.65 parts, 0.82 parts, 0.78 parts, 0.73 parts, 0.78 parts, 0.73 parts, 0.78 parts, 0.73 parts, 0.80 parts, 0.82 parts, 0.78 parts, 0.73 parts, 0.78 parts, 0.82 parts, 0.73 parts, 0.82 parts, 0., 0.95 part, 0.96 part, 0.97 part, 0.98 part, 0.99 part, 1 part, 1.1 part, 1.2 parts, 1.3 parts, 1.4 parts, 1.5 parts, 1.6 parts, 1.7 parts, 1.8 parts, 1.9 parts and 2 parts.
In the present application, the content of the centipeda minima volatile oil may be 0.08, 0.09, 0.1, 0.11, 0.12, 0.13, 0.14, 0.15, 0.16, 0.17, 0.18, 0.19, 0.2, 0.21, 0.22, 0.23, 0.24, 0.25, 0.26, 0.27, 0.28, 0.29, 0.3, 0.31, 0.32, 0.33, 0.34, 0.35, 0.36, 0.37, 0.38, 0.39, 0.4, 0.41, 0.42, 0.43, 0.44, 0.45, 0.46, 0.47, 0.65, 0.47, 0.64, 0.54, 0.65, 0.54, 0.67, 0.54, 0.73, 0.54, 0.75, 0.54, 0.73, 0.54, 0.27, 0.23, 0.7, 0.54, 0.7, 0.54, 0.7, 0.82 part, 0.83 part, 0.84 part, 0.85 part, 0.86 part, 0.87 part, 0.88 part, 0.89 part, 0.9 part, 0.91 part, 0.92 part, 0.93 part, 0.94 part, 0.95 part, 0.96 part, 0.97 part, 0.98 part, 0.99 part, 1.1 part, 1.2 parts, 1.3 parts, 1.4 parts and 1.5 parts.
In the present application, the content of tween-80 may be 0.1 part, 0.11 part, 0.12 part, 0.13 part, 0.14 part, 0.15 part, 0.16 part, 0.17 part, 0.18 part, 0.19 part, 0.2 part, 0.21 part, 0.22 part, 0.23 part, 0.24 part, 0.25 part, 0.26 part, 0.27 part, 0.28 part, 0.29 part, 0.3 part, 0.31 part, 0.32 part, 0.33 part, 0.34 part, 0.35 part, 0.36 part, 0.37 part, 0.38 part, 0.39 part, 0.4 part, 0.41 part, 0.42 part, 0.43 part, 0.44 part, 0.45 part, 0.46 part, 0.47 part, 0.48 part, 0.65 part, 0.64 part, 0.58 part, 0.54 part, 0.73 part, 0.66 part, 0.73 part, 0.27 part, 0.73 part, 0.27 part, 0.7.73 part, 0.73 part, 0.27, 0.84 part, 0.85 part, 0.86 part, 0.87 part, 0.88 part, 0.89 part, 0.9 part, 0.91 part, 0.92 part, 0.93 part, 0.94 part, 0.95 part, 0.96 part, 0.97 part, 0.98 part, 0.99 part, 1 part, 1.1 part, 1.2 part, 1.3 part, 1.4 part and 1.5 part.
In the application, the preparation process of the centipeda minima volatile oil comprises the following steps: weighing centipeda minima, placing the centipeda minima in a flask, adding 30-50 times of purified water, shaking and mixing, connecting the flask with a volatile oil tester and a reflux condenser pipe, adding water into the upper end of a self-condensing pipe to enable the water to fill the scale part of the volatile oil tester and overflow to the flask, heating the flask until boiling, and keeping slight boiling for 4-5 hours to obtain the centipeda minima volatile oil.
In the present application, the preparation method of the spray is:
dissolving glycerol and propylene glycol in a proper amount of purified water to obtain a solution A;
step two: adding tween-80 into the centipeda minima volatile oil, and uniformly mixing to obtain a solution B;
step three: and adding the solution B into the solution A under the condition of slow stirring, and uniformly stirring to obtain the spray.
The application provides a nasal drop, which comprises sodium hyaluronate, recombinant human epidermal growth factor and ectoin.
In the present application, the nasal drops comprise the following 100 parts by weight of nasal drops relative to the total weight:
sodium hyaluronate: 0.1 to 2.5 portions;
0.5 to 8 portions of ectoin;
0.0005 to 0.005 portion of recombinant human epidermal growth factor.
In the present application, the nasal drops comprise the following 100 parts by weight of nasal drops relative to the total weight:
sodium hyaluronate: 0.33 to 1.65 portions;
1 to 5 portions of ectoin;
0.001 to 0.003 portion of recombinant human epidermal growth factor.
In the present application, the sodium hyaluronate may be contained in an amount of 0.1 part, 0.11 part, 0.12 part, 0.13 part, 0.14 part, 0.15 part, 0.16 part, 0.17 part, 0.18 part, 0.19 part, 0.2 part, 0.21 part, 0.22 part, 0.23 part, 0.24 part, 0.25 part, 0.26 part, 0.27 part, 0.28 part, 0.29 part, 0.3 part, 0.31 part, 0.32 part, 0.33 part, 0.34 part, 0.35 part, 0.36 part, 0.37 part, 0.38 part, 0.39 part, 0.40 part, 0.41 part, 0.42 part, 0.43 part, 0.44 part, 0.45 part, 0.46 part, 0.47 part, 0.48 part, 0.39 part, 0.40 part, 0.41 part, 0.42 part, 0.43 part, 0.44 part, 0.45 part, 0.46 part, 0.47 part, 0.48 part, 0.65 part, 0.66 part, 0.65 part, 0.54 part, 0.71 part, 0.73 part, 0.71 part, 0.73 part, 0.65 part, 0.73 part, 0.71 part, 0.65 part, 0.73 part, 0.71 part, 0.73 part, 0.27 part, 0.65 part, 0.73 part, 0.27 part, 0.72 part, 0.71 part, 0.65 part, 0.75 part, 0.27 part, 0.84 part, 0.85 part, 0.86 part, 0.87 part, 0.88 part, 0.89 part, 0.9 part, 0.91 part, 0.92 part, 0.93 part, 0.94 part, 0.95 part, 0.96 part, 0.97 part, 0.98 part, 0.99 part, 1.00 part, 1.05 part, 1.1 part, 1.15 part, 1.2 part, 1.25 part, 1.3 part, 1.35 part, 1.4 part, 1.45 part, 1.5 part, 1.55 part, 1.6 part, 1.65 part, 1.7 part, 1.75 part, 1.8 part, 1.85 part, 1.9 part, 1.95 part, 2 parts, 2.05 part, 2.1 part, 2.15 part, 2.2 part, 2.25 part, 2.3 part, 2.35 part, 2.45 part.
In the present application, the content of ectoin may be 0.5 parts, 0.6 parts, 0.7 parts, 0.8 parts, 0.9 parts, 1 part, 1.1 parts, 1.2 parts, 1.3 parts, 1.4 parts, 1.5 parts, 1.6 parts, 1.7 parts, 1.8 parts, 1.9 parts, 2 parts, 2.1 parts, 2.2 parts, 2.3 parts, 2.4 parts, 2.5 parts, 2.6 parts, 2.7 parts, 2.8 parts, 2.9 parts, 3 parts, 3.1 parts, 3.2 parts, 3.3 parts, 3.4 parts, 3.5 parts, 3.6 parts, 3.7 parts, 3.8 parts, 3.9 parts, 4 parts, 4.1 parts, 4.2 parts, 4.3 parts, 4.4 parts, 5.5 parts, 4.6 parts, 7.7 parts, 6.8 parts, 7.9 parts, 6.5 parts, 6 parts, 7.6.6 parts, 7.7.6 parts, 7.6 parts, 7.6.5 parts, 7.6 parts, 7.5 parts, 7.6 parts, 7.6.6 parts, 7.6 parts, 7.6.6 parts, 7 parts, 7.6.6.6 parts, 7 parts, 7.6.6.6.6 parts, 7.6.6 parts, 7 parts, 7.6.6, 7 parts, 7.6 parts, 7.6, 7 parts, 7.6, 7 parts, 7.6.6, 8 parts.
In the present application, the recombinant human epidermal growth factor may be contained in an amount of 0.0005 parts, 0.001 parts, 0.0015 parts, 0.002 parts, 0.0025 parts, 0.003 parts, 0.005 parts, relative to 100 parts by weight of the total weight of the nasal drops.
In the application, the sodium hyaluronate comprises medium molecular sodium hyaluronate and small molecular sodium hyaluronate, wherein the molecular weight of the medium molecular sodium hyaluronate is 40 wDa-70 wDa, preferably 50 wDa-60 wDa; the molecular weight of the small-molecule sodium hyaluronate is 2500Da to 9500Da, preferably 3000Da to 8000 Da.
The molecular weight of the medium molecular sodium hyaluronate can be 40wDa, 41wDa, 42wDa, 43wDa, 44wDa, 45wDa, 46wDa, 47wDa, 48wDa, 49wDa, 50wDa, 51wDa, 52wDa, 53wDa, 54wDa, 55wDa, 56wDa, 57wDa, 58wDa, 59wDa, 60wDa, 61WDa, 62wDa, 63wDa, 64wDa, 65wDa, 66wDa, 67wDa, 68wDa, 69wDa and 70 wDa.
The molecular weight of the small-molecule sodium hyaluronate can be 2500Da, 2600Da, 2700Da, 2800Da, 2900Da, 3000Da, 3100Da, 3200Da, 3300Da, 3400Da, 3500Da, 3600Da, 3700Da, 3800Da, 3900Da, 4000Da, 4100Da, 4200Da, 4300Da, 4400Da, 4500Da, 4600Da, 4700Da, 4800Da, 4900Da, 5000Da, 8800Da, 5200Da, 5300Da, 5400Da, 5500, 5600Da, 5700Da, 5800Da, 5900Da, 6000Da, 6100Da, 6200Da, 6300Da, 6400Da, 6500Da, 6600Da, 6700Da, 6800Da, 6900Da, 7000, 7100Da, 7200, 7300, 7400, 7500Da, 7700, 7600, 7700Da, 7800, 7900, 90000, 8400Da, 8400, 8600, 8900, and 8600, 8400, 94 Da.
In the present application, the content of the medium-molecule sodium hyaluronate is 0.02 to 0.5 parts, preferably 0.03 to 0.15 parts, and the content of the small-molecule sodium hyaluronate is 0.08 to 2.0 parts, preferably 0.30 to 1.5 parts, relative to 100 parts by weight of the total nasal drop.
In the present application, the content of the medium molecular sodium hyaluronate may be 0.02 parts, 0.03 parts, 0.04 parts, 0.05 parts, 0.06 parts, 0.07 parts, 0.08 parts, 0.09 parts, 0.1 parts, 0.11 parts, 0.12 parts, 0.13 parts, 0.14 parts, 0.15 parts, 0.16 parts, 0.17 parts, 0.18 parts, 0.19 parts, 0.2 parts, 0.21 parts, 0.22 parts, 0.23 parts, 0.24 parts, 0.25 parts, 0.26 parts, 0.27 parts, 0.28 parts, 0.29 parts, 0.3 parts, 0.31 parts, 0.32 parts, 0.33 parts, 0.34 parts, 0.35 parts, 0.36 parts, 0.37 parts, 0.38 parts, 0.39 parts, 0.31 parts, 0.32 parts, 0.33 parts, 0.34 parts, 0.35 parts, 0.36 parts, 0.37 parts, 0.38 parts, 0.39 parts, 0.41 parts, 0.42 parts, 0.48 parts, 0.47 parts, 0.48 parts, 0.45 parts, 0.14 parts, 0.
In the present application, the content of the small molecule sodium hyaluronate may be 0.08 parts, 0.09 parts, 0.10 parts, 0.20 parts, 0.30 parts, 0.40 parts, 0.50 parts, 0.60 parts, 0.70 parts, 0.80 parts, 0.90 parts, 1.0 parts, 1.1 parts, 1.2 parts, 1.3 parts, 1.4 parts, 1.5 parts, 1.6 parts, 1.7 parts, 1.8 parts, 1.9 parts, 2.0 parts, relative to 100 parts by weight of the total nasal drop.
The small molecular weight sodium hyaluronate can be quickly absorbed by a human body to play a moisturizing and anti-inflammatory effect, and the medium molecular weight sodium hyaluronate can be attached to nasal mucosa to play a long-acting moisturizing effect, so that the treatment effect is prolonged.
The preparation method of the nasal drop comprises the following steps:
the method comprises the following steps: dissolving sodium hyaluronate in purified water, and stirring until the solution is clear and transparent to obtain solution C;
step two: and adding ectoin and human epidermal growth factor into the solution C under stirring, and uniformly stirring to obtain the nasal drop.
The application provides a nasal cavity medicine box, includes two independent compartments, has deposited spray and nose drop in two compartments respectively.
The nasal box of the application is used firstly by spraying agent and secondly by nasal drops. After the spray is acted on the nasal cavity, the nasal spray can quickly relieve congestion and swelling of nasal mucosa, slow nasal obstruction, shrink the nasal mucosa, enlarge the contact area of components of anti-inflammation and repair damaged nasal mucosa in the nasal drop and prolong the action time of effective components. The two dosage forms are matched for use, and have the effects of enlarging the nasal administration area, quickly preserving moisture, relieving nasal obstruction and nasal congestion and quickly repairing damaged nasal mucosa.
The application also provides a nasal cavity nursing method, after the spray is applied to the nasal cavity, the nasal drops are applied to the nasal cavity at intervals of 3-5 minutes.
The application also provides application of the spray and the nasal drops in preparation of the nasal cavity care solution.
Examples
The experimental methods used in the following examples are all conventional methods, unless otherwise specified.
Materials, reagents and the like used in the following examples are commercially available unless otherwise specified.
Example 1
A nasal cavity kit containing sodium hyaluronate comprises spray and nasal drop.
The preparation process of the spray comprises the following steps:
preparing centipeda minima volatile oil: taking 10kg of centipeda minima, placing the centipeda minima in a flask, adding 30 times of purified water, shaking and mixing, connecting the flask with a volatile oil tester and a reflux condenser pipe, adding water into the upper end of the self-condenser pipe to enable the water to fill the scale part of the volatile oil tester and overflow to the flask, heating the flask until boiling, and keeping slight boiling for 4 hours to obtain the centipeda minima volatile oil.
The method comprises the following steps: 1kg of glycerol and 0.2kg of propylene glycol are weighed and dissolved in purified water to obtain a solution A.
Step two: weighing 0.08kg of centipeda minima volatile oil, adding 0.08kg of tween-80 into the centipeda minima volatile oil, and uniformly mixing to obtain a solution B.
Step three: and adding the solution B into the solution A under the condition of slow stirring, and uniformly stirring to obtain the spray.
The preparation process of the nasal drop comprises the following steps:
the method comprises the following steps: weighing 0.02kg of sodium hyaluronate with a medium molecular weight of 40wDa and 0.08kg of sodium hyaluronate with a small molecular weight of 2500Da, dissolving in purified water, and stirring until the solution is clear and transparent to obtain solution C;
step two: weighing 0.5kg of ectoin and 0.0005kg of human epidermal growth factor, adding into the solution C under stirring, and stirring to obtain the nasal drop.
Examples 2 to 8 and comparative examples 1 to 3 are different from example 1 in the content of medium molecular weight sodium hyaluronate, small molecular weight sodium hyaluronate, glycerin, propylene glycol, ectoin, recombinant human epidermal growth factor, and centipeda minima volatile oil, and the specific parameters are shown in table 1.
Comparative example 4 differs from example 3 in that it does not contain centipeda minima essential oil, the specific parameters are shown in table 1.
Comparative example 5 differs from example 3 in that it does not contain medium molecular weight sodium hyaluronate, and the specific parameters are shown in table 1.
Comparative example 6 differs from example 3 in that it does not contain small molecular weight sodium hyaluronate, and the specific parameters are shown in table 1.
Comparative example 7 differs from example 3 in that no ectoin is present and the specific parameters are shown in table 1.
Comparative example 8 differs from example 3 only in that sprays were prepared, with specific parameters as shown in table 1.
Comparative example 9 differs from example 3 only in that nasal drops were prepared, the specific parameters being shown in table 1.
Comparative example 10 differs from example 3 in that all ingredients are prepared as nasal drops.
Comparative example 11 is oxymetazoline hydrochloride nasal drops (manufacturer: heilongjiang tianlong pharmaceutical co., ltd.).
Table 1 is a comparative table of raw material compositions of examples and comparative examples
Test examples
1. Observation of effects of use
190 subjects with dry nasal conditions were selected, 10 individuals for each example, and male and female halves. The using method comprises the following steps: the spray is firstly used, the nasal cavities on two sides are respectively sprayed by 2 times at each time, the drops are used after 5 minutes, the nasal cavities on two sides are respectively sprayed by 2-3 times at each time, 4-5 times every day, and the nasal drops are used for 30 days. And (4) counting whether the symptoms of nasal dryness, nasal bleeding, nasal allergy and the like of the patient are relieved after the patient uses the nasal mask. The statistical results are shown in Table 2.
TABLE 2 statistical table for observing use effect of each example and comparative example
And (3) knotting: from the above table, the nasal cavity medicine box prepared by the application has a definite curative effect on relieving nasal dryness and epistaxis symptoms, and particularly when the molecular weight of the medium molecular sodium hyaluronate in the spray is 50-70wDa, the content is 0.03-0.15 part, the molecular weight of the small molecular sodium hyaluronate is 2500-9500Da, the content is 0.3-1.5 parts, the content of ectoine is 1-5 parts, the content of the recombinant human epidermal growth factor is 0.001-0.003 part, when the content of glycerin in the nasal drop is 2-3 parts, the content of propylene glycol is 0.5-1 part, and the content of the centipeda minima volatile oil is 0.25-1 part, and when the nasal drop is used after the spray is used, the nasal dryness, epistaxis and nasal sensitivity relieving effects are best.
2. Observation of moisturizing Effect
The nasal cavity medicine box is dyed by edible indigo, 190 subjects with xerostomia are selected, 10 persons in each group of examples or comparative examples are used according to the using method in the test example 1, different parts of nasal cavity mucosa are stained by a medical cotton swab every 1 hour, the number of dyed examples is counted, the large number of dyed examples indicates that the moisturizing effect of the nasal cavity medicine box or the nasal cavity medicine box is good, and the counting condition is shown in table 3.
TABLE 3 statistical tables of nasal cavity staining of subjects in examples and comparative examples
And (3) knotting: from the above table, the nasal cavity kit of the application has the effect of long-acting moisture retention, and particularly when the molecular weight of the sodium hyaluronate in the spray is 50-70wDa, the content is 0.03-0.15, the molecular weight of the sodium hyaluronate in the small molecule is 2500-9500Da, the content is 0.3-1.5, the content of the ectoin is 1-5, the content of the recombinant human epidermal growth factor is 0.001-0.003, and when the content of the glycerol in the nasal drop is 2-3, the content of the propylene glycol is 0.5-1, and the content of the centipeda minima volatile oil is 0.25-1, the long-acting moisture retention effect is the best.
3. Observation of Effect of repairing damaged nasal mucosa
190 rats adapted to a breeding environment in a laboratory are prepared into a solution with the concentration of 10 percent by using olive oil and toluene-2, 4-diisocyanate to be used as a sensitizing agent, 5 mu L of the solution is dripped into the nose, 1 time is taken every day for 7 days continuously, then the solution is dripped into the nose once every 2 days for 4 times, and the sensitization time is 15 days totally, so that a rat allergic rhinitis model is established. After 15 days, the nasal mucosa was confirmed to be damaged significantly. Rats with damaged nasal mucosa were randomly divided into 19 groups, and 10 rats per group were used in each example and comparative example. The nasal cavity kit prepared in the above examples and comparative examples was dropped into the nasal cavity of a rat at 5. mu.L per side 2 times a day for 7 days, and the repair of the nasal mucosa of the rat was observed at regular time each day and counted. Whether the nasal secretion and nasal obstruction of the rat nose are normal or not in the experimental process is taken as an index of whether the nasal cavity and the nasal mucosa are normal or not (refer to the research on the damage effect of panxinyu, cheng wen yuan, wang qing chun, Lihong, Liu Qi, Lu Hui Jie. insulin nasal drops on the nasal mucosa of the rat [ J ]. The repair of damaged nasal mucosa in rats is shown in Table 4.
TABLE 4 statistical tables of the damaged nasal mucosa repair conditions of rats in each example and comparative example
From the above table, the nasal cavity kit of the application has the effect of rapidly repairing damaged nasal mucosa, and especially when the molecular weight of the medium molecular sodium hyaluronate in the spray is 50-70wDa, the content is 0.03-0.15 parts, the molecular weight of the small molecular sodium hyaluronate is 2500-9500Da, the content is 0.3-1.5 parts, the content of ectoin is 1-5 parts, the content of the recombinant human epidermal growth factor is 0.001-0.003 parts, and when the content of glycerin in the nasal drop is 2-3 parts, the content of propylene glycol is 0.5-1 part, and the content of the centipeda minima volatile oil is 0.25-1 part, the effect of rapidly repairing damaged nasal mucosa is the best.
While embodiments of the present application have been described above in connection with specific embodiments thereof, the present application is not limited to the above-described embodiments and fields of application, which are intended to be illustrative, instructive, and not restrictive. Those skilled in the art, having the benefit of this disclosure, may effect numerous modifications thereto and changes may be made without departing from the scope of the invention as defined by the appended claims.
Claims (10)
1. A spray is characterized by comprising glycerol, propylene glycol, centipeda minima volatile oil and tween-80.
2. The spray according to claim 1, which comprises the following 100 parts by weight of spray relative to the total weight:
3. the spray according to claim 1, which comprises the following 100 parts by weight of spray relative to the total weight:
4. the spray according to any one of claims 1 to 3, wherein the preparation process of the centipeda minima volatile oil comprises the following steps: weighing centipeda minima, placing the centipeda minima in a flask, adding 30-50 times of purified water, shaking and mixing, connecting the flask with a volatile oil tester and a reflux condenser pipe, adding water at the upper end of a self-condensing pipe to enable the water to fill the scale part of the volatile oil tester and overflow to the flask, heating the flask until boiling, and keeping slight boiling for 4-5 hours to obtain the centipeda minima volatile oil.
5. A nasal drop is characterized by comprising sodium hyaluronate, recombinant human epidermal growth factor and ectoin.
6. The nasal drop according to claim 5, characterized by comprising the following 100 parts by weight of nasal drop relative to the total weight:
sodium hyaluronate: 0.1 to 2.5 portions;
0.5 to 8 portions of ectoin;
0.0005 to 0.005 portion of recombinant human epidermal growth factor.
7. The nasal drop according to claim 5, characterized by comprising the following 100 parts by weight of nasal drop relative to the total weight:
sodium hyaluronate: 0.33 to 1.65 portions;
1 to 5 portions of ectoin;
0.001 to 0.003 portion of recombinant human epidermal growth factor.
8. The nasal drop according to any one of claims 5 to 7, wherein the sodium hyaluronate comprises medium molecular sodium hyaluronate and small molecular sodium hyaluronate, wherein the medium molecular sodium hyaluronate has a molecular weight of 40 wDa-70 wDa, preferably 50 wDa-60 wDa; the molecular weight of the small-molecule sodium hyaluronate is 2500Da to 9500Da, preferably 3000Da to 8000 Da.
9. The nasal drop according to claim 8, wherein the content of the medium-molecule sodium hyaluronate is 0.02-0.5 parts, preferably 0.03-0.15 parts, and the content of the small-molecule sodium hyaluronate is 0.08-2.0 parts, preferably 0.30-1.5 parts, relative to 100 parts by weight of the total nasal drop.
10. A nasal cavity medicine box is characterized by comprising two independent containers, wherein spray and nasal drops are respectively stored in the two containers.
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Application publication date: 20200911 |