CN114377064A - Gargle for treating oral ulcer - Google Patents

Gargle for treating oral ulcer Download PDF

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Publication number
CN114377064A
CN114377064A CN202210228384.7A CN202210228384A CN114377064A CN 114377064 A CN114377064 A CN 114377064A CN 202210228384 A CN202210228384 A CN 202210228384A CN 114377064 A CN114377064 A CN 114377064A
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China
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parts
gargle
ulcer
oral ulcer
sorbitol
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CN202210228384.7A
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Chinese (zh)
Inventor
徐珍燕
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Jiangsu Yi Ren Tang Biotechnology Co ltd
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Jiangsu Yi Ren Tang Biotechnology Co ltd
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Priority to CN202210228384.7A priority Critical patent/CN114377064A/en
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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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • 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
    • 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)
    • A61K36/19—Acanthaceae (Acanthus family)
    • 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)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • 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)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258—Panax (ginseng)
    • 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)
    • A61K36/32—Burseraceae (Frankincense family)
    • 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)
    • A61K36/82—Theaceae (Tea family), e.g. camellia
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis

Abstract

The invention discloses a gargle for treating dental ulcer, which relates to the technical field of medical instruments and comprises the following components: the repairing agent comprises, by weight, 6-12 parts of borneol, 12-19 parts of pseudo-ginseng, 0.5-2 parts of benzyl alcohol, 3-12 parts of clinacanthus nutans, 0.1-0.5 part of glucan, 20-30 parts of camellia chrysantha and 8-11 parts of Chinese olive, and the gel comprises water, kudzu root starch, glycerol, carbomer, propylene glycol and sorbitol. The gargle can form a protective layer on the surface of ulcer or the wound surface of tissue by adding the film-forming high polymer, the medicinal auxiliary materials for treating inflammation, the preservative, the sweetening agent and the pH regulator, and has the effect of physically shielding the wound.

Description

Gargle for treating oral ulcer
Technical Field
The invention relates to the technical field of medical instruments, in particular to a gargle for treating dental ulcer.
Background
The oral cavity is one of key modes of microorganism invasion to the body, the patient is subjected to oral infection due to the factors of food prohibition, drinking prohibition, tracheotomy, immunity reduction and the like, the oral ulcer is an oral mucosa disease which is relatively extensive in clinical medicine, the name of the oral ulcer is named as oral ulcer, the oral ulcer is superficial ulcer generated on the oral mucosa, the size of the superficial ulcer can be from small rice grains to soybean size, and the superficial ulcer is annular or elliptical, the ulcer surface is concave and peripheral hematoma, pain can be caused due to food containing irritation, the superficial ulcer is commonly found in positions such as the inner lip, the mouth, the tongue abdomen, the buccal mucosa, vestibular functional sulcus, soft palate and the like, the mucosa in the position is lack of a cutin hardened layer or is weak in keratinization, the tongue ulcer refers to the oral ulcer generated in the mouth and the tongue abdomen, and in order to facilitate the oral ulcer, the existing mode mostly adopts a gargle mode.
The existing gargle only has simple effects of diminishing inflammation and relieving pain, and the actual effect is not obvious.
Disclosure of Invention
The invention aims to provide the gargle for treating the dental ulcer, which has the advantages that by adding the film-forming high polymer, the medicinal auxiliary materials for treating inflammation, the preservative, the sweetening agent and the PH regulator, the gargle can form a protective layer on the surface of the dental ulcer or the wound surface of the tissue, and the effect of physically shielding the wound is achieved, so that the problems in the background technology are solved.
In order to achieve the purpose, the invention provides the following technical scheme: an oral ulcer gargle comprises the following components: a treatment and repair agent, a gel, a flavoring agent, a preservative and purified water.
Optionally, the treatment and repair agent comprises 20-50 parts of a gel, 80-95 parts of a taste-raising agent, 2-5 parts of a preservative and 25-35 parts of purified water.
Optionally, the therapeutic and restorative agent includes borneol, panax notoginseng, benzyl alcohol, clinacanthus nutans, dextran, camellia chrysantha leaves and olive.
Optionally, the therapeutic and repairing agent comprises 6-12 parts by weight of borneol, 12-19 parts by weight of panax notoginseng, 0.5-2 parts by weight of benzyl alcohol, 3-12 parts by weight of clinacanthus nutans, 0.1-0.5 part by weight of glucan, 20-30 parts by weight of camellia chrysantha and 8-11 parts by weight of Chinese olive.
Optionally, the gelling agent comprises water, kudzu starch, glycerin, carbomer, propylene glycol and sorbitol.
Optionally, the gel comprises, by weight, 75-95 parts of water, 22-28 parts of kudzu root starch, 0.5-2.4 parts of glycerol, 0.2-0.4 part of carbomer, 20-45 parts of propylene glycol and 2-4 parts of sorbitol.
Optionally, the taste enhancer comprises sodium saccharin and sorbitol.
Optionally, the taste-extracting agent comprises, by weight, 0.2-0.8 part of saccharin sodium and 0.07-0.2 part of sorbitol.
Compared with the prior art, the invention has the following beneficial effects:
the borneol is prepared to stimulate the wound to form a cool feeling, so that the pain is relieved; the pseudo-ginseng can facilitate the healing of the wound; the benzyl alcohol can be used as a sedative on one hand, and also has the bacteriostatic effect on the other hand; clinacanthus nutans has effects of clearing heat and detoxicating, removing blood stasis and detumescence, and diminishing inflammation and relieving alcoholism; the glucan can effectively adjust the micro-ecology in the oral cavity of a human body so as to achieve the protective functions of promoting the proliferation of beneficial bacteria in the oral cavity, decomposing harmful substances and stimulating the activity of skin cells; the camellia nitidissima tea has the effects of clearing away heat and toxic materials, resisting bacteria and diminishing inflammation; the fructus Canarii albi has effects of removing toxic substances and sticking.
The adhesive force between the gargle and the wound can be improved by preparing the kudzu root starch, and a durable film can be formed, so that the formed film is prevented from being easily removed by saliva; the matching substance of the glycerol and the carbomer forms a moisturizing film on the wall in the oral cavity, so that the pain caused by the wound surface due to the dental ulcer and the stomatitis is relieved.
Thirdly, the oral collutory has better taste by preparing the saccharin sodium and the sorbitol, wherein the saccharin sodium can be used as a flavoring agent, and the sorbitol can improve the taste of the collutory so as to cover up the bitter taste.
Drawings
FIG. 1 is a schematic diagram of the components of the structure of the present invention.
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.
Referring to fig. 1, the present embodiment provides a technical solution: an oral ulcer gargle comprises the following components: a treatment and repair agent, a gel, a flavoring agent, a preservative and purified water.
More specifically, in this embodiment, through the preparation of multiple Chinese herbal medicines of the treatment and repair agent, a certain repair effect is achieved under the condition of relieving pain of a patient, the gel can form a protective film at the patient, so as to greatly reduce the pain, the taste-raising agent can be conveniently used by a user, the condition of uncomfortable entrance caused by bitterness is reduced, and the preservative is used for prolonging the shelf life of the product.
Further, in the embodiments: 20-50 parts of a treatment and repair agent, 80-95 parts of a gel, 2-5 parts of a taste-raising agent, 1-5 parts of a preservative and 25-35 parts of purified water.
More specifically, in this example, 45 parts of the therapeutic restoration agent, 90 parts of the gelling agent, 4 parts of the flavor enhancer, 3 parts of the preservative and 30 parts of purified water are added.
Further, in the embodiments: the therapeutic and repairing agent comprises Borneolum Syntheticum, Notoginseng radix, benzyl alcohol, Clinacanthus nutans, dextran, Camellia Chysantha and fructus Canarii albi.
More specifically, in the embodiment, the borneol can stimulate the wound to form a cool feeling, which is beneficial to relieving the pain; the pseudo-ginseng can facilitate the healing of the wound; the benzyl alcohol can be used as a sedative on one hand, and also has the bacteriostatic effect on the other hand; clinacanthus nutans has effects of clearing heat and detoxicating, removing blood stasis and detumescence, and diminishing inflammation and relieving alcoholism; the glucan can effectively adjust the micro-ecology in the oral cavity of a human body so as to achieve the protective functions of promoting the proliferation of beneficial bacteria in the oral cavity, decomposing harmful substances and stimulating the activity of skin cells; the camellia nitidissima tea has the effects of clearing away heat and toxic materials, resisting bacteria and diminishing inflammation; the fructus Canarii albi has effects of removing toxic substances and sticking.
Further, in the embodiments: the treatment and repair agent comprises, by weight, 6-12 parts of borneol, 12-19 parts of pseudo-ginseng, 0.5-2 parts of benzyl alcohol, 3-12 parts of clinacanthus nutans, 0.1-0.5 part of glucan, 20-30 parts of camellia chrysantha and 8-11 parts of Chinese olive.
More specifically, the components of the therapeutic restoration agent in this example are specifically 11 parts of borneol, 13 parts of pseudo-ginseng, 0.5 part of benzyl alcohol, 3.2 parts of clinacanthus nutans, 0.3 part of glucan, 22 parts of camellia chrysantha and 10 parts of Chinese olive.
Further, in the embodiments: the gel comprises water, radix Puerariae starch, glycerol, carbomer and propylene glycol.
More specifically, in the embodiment, the kudzu root starch can improve the bonding strength of the gargle and the wound, and can form a durable film to prevent the formed film from being easily removed by saliva; the matching substance of the glycerol and the carbomer forms a moisturizing film on the wall in the oral cavity, so that the pain caused by the wound surface due to the dental ulcer and the stomatitis is relieved.
Further, in the embodiments: the gel comprises, by weight, 75-95 parts of water, 22-28 parts of kudzu root starch, 0.5-2.4 parts of glycerol, 0.2-0.4 part of carbomer and 20-45 parts of propylene glycol.
More specifically, in this embodiment, the components of the therapeutic and repair agent are 82 parts of water, 25 parts of pueraria starch, 1.2 parts of glycerin, 0.3 part of carbomer, 30 parts of propylene glycol and 2.7 parts of sorbitol.
Further, in the embodiments: the taste-enhancing agent comprises saccharin sodium and sorbitol.
More specifically, in this embodiment, the saccharin sodium can be used as a flavoring agent to make the oral collutory have a better taste, and the sorbitol can improve the mouth feel of the collutory to mask the bitter taste.
Further, in the embodiments: the taste-extracting agent comprises 0.2-0.8 part of saccharin sodium and 0.07-0.2 part of sorbitol according to parts by weight.
More specifically, the flavor enhancer in this example comprises saccharin sodium 0.6 parts and sorbitol 0.11 parts.
Firstly, the working principle is as follows: when the gargle for dental ulcer is used, the gargle can be changed into hydrogel and can be filled in the whole oral cavity along with the secretion and neutralization of saliva in the oral cavity of a user, a protective film is formed on the surface of the oral ulcer, a wound is physically shielded, pain caused by the oral ulcer, oral inflammation, tiny wound caused by braces or false teeth is relieved, the gel also has a certain hemostatic effect, the gel can interact with mucosa glycoprotein by utilizing the specific biological adhesion of carbomer to form physical entanglement, then hydrogen bonds are formed with sugar residues on glycoprotein recruiting chains to generate a strong mucus gel network structure, a protective film can be formed on the oral mucosa, when a patient who physically shields the wound is in gargle for dental ulcer, a protective film with positive charges can be formed in the oral cavity, and the damaged oral mucosa and the microenvironment of the oral cavity are isolated, provides a good environment for the restoration of the oral cavity, the saliva secreted by the oral cavity of a common human is neutral (the pH is between 6.5 and 7.5), the components of carbomer and maltodextrin in the gargle have a large amount of carboxyl on the surface, are weakly acidic, when the carboxyl on the surface of the molecule is neutralized, the carbomer with high molecular weight and the maltodextrin are mutually crosslinked to form hydrogel which can be filled in the whole oral cavity, forming a protective film on the surface of the oral ulcer, physically shielding the wound, relieving pain caused by the micro wound caused by the oral ulcer, the stomatitis, the braces or the false teeth, and a layer of space polymer network structure formed on the surface of the window by the gel can be used for adsorbing platelets and promoting the coagulation of the oozing blood of the wound surface, therefore, the gargle for treating dental ulcer has a certain hemostatic effect, is safe and effective in the treatment of dental ulcer, and is worthy of popularization.
The use method of the gargle comprises the following steps:
type A: pulling off the cover cap, aiming at ulcer mucosa tissue, spraying uniformly 2-4 times (about 0.2m1) per square centimeter, spraying 3-5 times per day with a spray pump with a spray volume of about 0.05ml each time, and continuing to spray for 7-10 days or following the medical advice.
Type B: slowly pouring 5ml of gargle into oral cavity, and keeping in oral cavity for at least 1 min while gargling, and if gargling is inconvenient or pain is obvious, lightly rotating head to apply gargle to whole oral cavity and ensure sufficient coverage, and adding 10ml if necessary. After gargling, the liquid is spitted out, and the liquid is safe to swallow if the liquid is carelessly swallowed. For treating oral mucositis/stomatitis, the prescription is recommended to be used for 4-6 times per body or according to medical advice.
Thirdly, the gargle is packaged as follows:
1. the primary packaging materials are all polyethylene packaging bottles, and can be divided into A, B types according to different pump heads, wherein the type A is a spraying pump head, and the type B is a flat head; the specification is as follows: 30 ml/bottle, 50 ml/bottle, 80 ml/bottle, 100 ml/bottle, 200 ml/bottle.
2. Appearance of the bottle: visual inspection shows that the surface has uniform color, no obvious color difference, smooth and flat surface, no deformation, no obvious scratch, no sand hole, oil stain and air bubble, and smooth bottle mouth.
Sealing property: the bottle mouth and the bottle cap are matched properly, no sliding teeth exist, and no water is fed into the bottle or bubbles are generated in the bottle.
Drop resistance: the bottle and the bottle cap are not broken in the drop test.
The microbial limit: the product is taken and operated according to the microbial test standard, and the total number of aerobic bacteria is less than or equal to 200cfu/ml, and the total number of mould and microzyme is less than or equal to 20 cfu/ml.
Particle contamination: each lml of leaching liquor contains particles with the size of 10 mu m and more than 10 mu m and particles with the size of 25 mu m and more than 25 mu m, and the number of particles in each lml of leaching liquor is not more than 300, and not more than 150.
White board box: appearance: the visual inspection shows that the appearance is complete, the box is not damaged, the inside and the outside of the box are clean and tidy, no bubbles exist, no wrinkles exist, the edge cutting is tidy, and no burrs exist.
Size: the dimensions should be 32X 105mm with a tolerance of + -5 mm, measured with a universal measuring tool.
Fourthly, the physical properties of the main materials in the gargle are as follows:
1. maltodextrin
Color: white or with light yellow colour
Odor: has no peculiar smell
The state is as follows: powder or crystalline state, no foreign body visible with normal vision.
pH value: should be in the range of 4.5-6.5.
2. Propylene glycol
The characteristics are as follows: the product is colorless viscous stable water-absorbing liquid.
And (3) performance detection: the content should be more than or equal to 99.5%
3. Carbomer 940
The characteristics are as follows: the product is white loose powder, and has special odor and hygroscopicity.
And (3) performance detection: the purity is more than or equal to 85 percent, and the water content is less than or equal to 2.0 percent.
4. Sorbitol
The characteristics are as follows: the product is white powder, flake or granule, and has hygroscopic property.
pH value: should be in the range of 3.5-7.0.
The content is as follows: should be in the range of 91.0% to 100.5%.
The microbial limit: according to the microbial limit inspection operation of 1105 in the four-part general rules of pharmacopoeia of the people's republic of China 2015, the total number of aerobic bacteria is less than or equal to 1000cfu/g, and the total number of mould and yeast is less than or equal to 100 cfu/g.
5. Potassium sorbate
The characteristics are as follows: the product is white or white-like scaly tablet or granular crystal or crystalline powder.
pH value: taking 10ml of the product, adding 2 drops of methyl red indicator, and preventing the product from appearing red; 10ml of the product is taken and added with 5 drops of bromothymol blue indicator, and the blue color cannot be developed.
The content is as follows: should be greater than or equal to 99.0%.
Fifthly, the performance indexes of the gargle are as follows:
1. appearance: the mouth ulcer gargle is colorless liquid, has no foreign matter, and the polyethylene bottle should not leak liquid, and has clear, accurate and complete characters.
2. Loading: the average loading is not less than the marked loading. The filling amount of 20-50 ml per bottle is not less than 95% of the marked filling amount; the content of more than 50ml in each bottle is not less than 97% of the marked content.
3. Spray volume (applicable to type a): the gargle for treating dental ulcer should form a spray shape during the spraying process, and should not be blocked. The spray specification is 0.05 mL-0.1 mL/time, and the average value of the spray amount for 20 consecutive times should not exceed the predetermined amount.
4. Viscosity: the viscosity of the gargle for treating dental ulcer is 100 and 1000 mpa.s.
pH value: the pH value of the oral ulcer gargle is within the range of 5.5-7.5.
6. Heavy metals: heavy metal of the gargle for treating dental ulcer should not be more than 10ug/g
7. Drop resistance: the product can fall to the ground freely from the height of 70cm, the bottle body and the outer cover can not be cracked, and the product liquid in the bottle can not leak.
8. The microbial limit: the total number of aerobic bacteria in the oral ulcer gargle is less than or equal to 100 cfu/ml; the total number of the mould and the microzyme is less than or equal to 10 cfu/ml.
Sixth, the gargle inspection method:
1. appearance: the requirement of 2.1 is met by visual inspection under normal illumination.
2. Loading: taking 5 samples (more than 50ml, 3 samples), opening to avoid loss, transferring the content into a pre-standardized dry volume-in measuring cylinder (the measuring tool is sized to enable the volume to be measured to at least occupy 40% of the rated volume), reading the content of the content in the container, and calculating the average content to meet the requirement of 2.2.
3. Spray volume (applicable to type a): optionally taking 2 bottles of A-type oral collutory, slightly pressing the valve of the spray tank for 5 times, inserting the nozzle into a clean and dry measuring cylinder, continuously spraying for 20 times, and calculating the average value of the sprayed amount of each time, wherein the average value is required to meet the regulation of 2.3.
4. Viscosity: 250ml of the product is taken and measured by a rotor type rotational viscometer according to the measurement method of a rotational viscometer, and the requirement of 2.4 is met.
pH value: taking 50ml of the product, and measuring by using an acidimeter, wherein the requirement of 2.5 is met.
6. Heavy metals: taking three 25ml nano colorimetric tubes, adding a certain amount of standard lead solution and 2ml of acetate buffer solution (PH3.5) into a tube A, adding water or a solvent specified under various items to dilute into 25ml, adding a test sample with the same weight as that of the tube B into a tube C, adding a proper amount of solvent for preparing the test sample solution to dissolve, adding 2ml of standard lead solution and 2ml of acetate buffer solution (PH3.5) with the same amount as that of the tube A, and diluting into 25ml by using the solvent; the requirement of 2.6 should be met.
7. Drop resistance: the product can fall to the ground freely from the height of 70cm, the bottle body and the outer cover can not be cracked, the product liquid in the bottle can not leak, and the requirement of 2.7 is met.
8. The microbial limit: the detection is carried out according to methods 1105 and 1106 of the general rules of the four parts of the Chinese pharmacopoeia of 2020 edition. The detection result meets the requirement of 2.8.
Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.

Claims (8)

1. The gargle for treating dental ulcer is characterized in that: comprises the following components: a treatment and repair agent, a gel, a flavoring agent, a preservative and purified water.
2. The oral ulcer gargle of claim 1, wherein: the paint comprises the following components in parts by weight: 20-50 parts of treatment and repair agent, 80-95 parts of gel, 2-5 parts of flavor-extracting agent, 1-5 parts of preservative and 25-35 parts of purified water.
3. The oral ulcer gargle according to claim 1 or 2, wherein: the therapeutic and repairing agent comprises Borneolum Syntheticum, Notoginseng radix, benzyl alcohol, Clinacanthus nutans, dextran, Camellia chrysantha and fructus Canarii albi.
4. The oral ulcer gargle of claim 1, wherein: the treatment and repair agent comprises, by weight, 6-12 parts of borneol, 12-19 parts of pseudo-ginseng, 0.5-2 parts of benzyl alcohol, 3-12 parts of clinacanthus nutans, 0.1-0.5 part of glucan, 20-30 parts of camellia chrysantha leaves and 8-11 parts of Chinese olive.
5. The oral ulcer gargle of claim 1, wherein: the gel comprises water, kudzu root starch, glycerin, carbomer, propylene glycol and sorbitol.
6. The oral ulcer gargle of claim 1, wherein: the gel comprises, by weight, 75-95 parts of water, 22-28 parts of kudzu root starch, 0.5-2.4 parts of glycerol, 0.2-0.4 part of carbomer, 20-45 parts of propylene glycol and 2-4 parts of sorbitol.
7. The oral ulcer gargle of claim 1, wherein: the taste-enhancing agent comprises saccharin sodium and sorbitol.
8. The oral ulcer gargle of claim 1, wherein: the taste-extracting agent comprises, by weight, 0.2-0.8 part of saccharin sodium and 0.07-0.2 part of sorbitol.
CN202210228384.7A 2022-03-10 2022-03-10 Gargle for treating oral ulcer Pending CN114377064A (en)

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