CN112107543A - Throat spray and its preparation method - Google Patents
Throat spray and its preparation method Download PDFInfo
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- CN112107543A CN112107543A CN201910530964.XA CN201910530964A CN112107543A CN 112107543 A CN112107543 A CN 112107543A CN 201910530964 A CN201910530964 A CN 201910530964A CN 112107543 A CN112107543 A CN 112107543A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—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
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K47/38—Cellulose; Derivatives thereof
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- 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
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- 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
- A61P11/04—Drugs for disorders of the respiratory system for throat disorders
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Abstract
The invention relates to a throat spray for relieving dry mouth and throat and a preparation method thereof, belonging to the technical field of medical use and health care and the technical field of medical pharmaceutical machinery. The throat spray consists of 2.0 to 8.0 weight percent of polysorbate 80, 10 to 25 weight percent of glycerin, 0.3 to 1.0 weight percent of sodium chloride, 0.1 to 0.8 weight percent of sodium edetate, 0.05 to 0.3 weight percent of sodium carboxymethyl cellulose, 0.1 to 0.5 weight percent of citric acid, 0.1 to 0.5 weight percent of sodium citrate, 0.2 to 0.5 weight percent of potassium sorbate and the balance of purified water, and has excellent biocompatibility and moisture retention performance after the processes of liquid preparation, filling and the like. The product does not contain antibiotics and hormone, and has no toxicity, irritation and sensitization to human body. Has no any harm and high safety. The large-scale production process is simple and convenient, and the production process does not pollute the environment.
Description
Technical Field
The invention relates to the technical field of medical treatment and health care and the technical field of medical instruments, in particular to a throat spray and a preparation method thereof.
Background
Dry oropharynx is the result of a negative balance between salivary secretion and consumption in the oral cavity, resulting in dry oropharynx, due to a decrease in secretion or an increase in consumption of saliva in the oral cavity for various reasons. With the improvement of the life quality of people and the enhancement of self-health care consciousness, more and more patients are hospitalized with xerostomia and pharyngeal dryness, which accounts for about 10 percent of the population; in older people of 65 years, the xerostomia patients exceed 30%.
The reasons for causing the dry mouth and throat are various, at present, clinical perioperative period such as pancreas operation patients are fasted and forbidden to drink water, and the patients have dry mouth symptoms and even have cracks and ulcers because the patients cannot drink water directly; for tumor patients and radiotherapy and chemotherapy patients, the mouth dryness of the patients is caused by the reduction of salivary secretion caused by the damage of chemotherapy drugs and radiation to salivary glands, the mind and physiology of the patients are damaged, and even the normal life of the patients is endangered; also comprises dry mouth of the elderly, side effects of drug administration, snoring, acute and chronic pharyngitis, and dry mouth and throat caused by excessive use of throat.
At present, the application of some medicines is aimed, such as the effect of cyclopentanethione on the increase of salivary secretion in mild salivary dysfunction patients. However, the medicine is expensive and has a large side effect, and it is impossible to use the medicine for a long period of time for patients with chronic diseases of dry mouth, such as diabetes. Meanwhile, various mouthwashes or saliva substitutes for relieving xerostomia appear in the market, for example, flaxseed gum is used as a main component, has special taste and is not easy to be accepted by patients. With the increase of similar products, people put forward new requirements on the mouth feel, efficacy and safety of throat products, and especially the requirements on the mouth feel even exceed the efficacy.
In view of the above, there is still a need in the art to provide a throat spray which has lasting moisture retention, good taste, good patient compliance, high safety, and can be used for a long time to effectively relieve dry mouth and throat.
Disclosure of Invention
The invention aims to solve the problems in the prior art and provide a throat spray for relieving xerostomia and throat dryness and a preparation method thereof.
In a first aspect of the invention, there is provided a composition comprising polysorbate 80, glycerol, sodium chloride, sodium edetate, sodium carboxymethylcellulose, citric acid, sodium citrate, potassium sorbate and purified water.
Preferably, the composition comprises, in mass percent: polysorbate 80 accounts for 2.0-8.0%, glycerin accounts for 10-25%, sodium chloride accounts for 0.3-1.0%, sodium edetate accounts for 0.1-0.8%, sodium carboxymethylcellulose accounts for 0.05-0.3%, citric acid accounts for 0.1-0.5%, sodium citrate accounts for 0.1-0.5%, potassium sorbate accounts for 0.2-0.5%, and purified water accounts for 70-90%.
Preferably, the composition comprises, in mass percent: polysorbate 80 at 2.0%, 3.0%, 4.0%, 5.0%, 6.0%, 7.0%, or 8.0%; glycerol comprises 10%, 12%, 15%, 18%, 20%, 22% or 25%; sodium chloride accounts for 0.3%, 0.5%, 0.8% or 1.0%; sodium edetate accounts for 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7% or 0.8%; sodium carboxymethylcellulose accounts for 0.05%, 0.08%, 0.1%, 0.15%, 0.18%, 0.2%, 0.25%, 0.3%; citric acid accounts for 0.1%, 0.2%, 0.3%, 0.4% or 0.5%; sodium citrate accounts for 0.1%, 0.2%, 0.3%, 0.4% or 0.5%; potassium sorbate accounts for 0.2%, 0.3%, 0.4% or 0.5%; purified water comprises 70%, 75%, 78%, 80%, 81%, 81.3%, 82%, 83%, 85%, 88%, 89% or 90%.
In a second aspect of the invention, the application of the composition in preparing a medicine for relieving dry mouth and throat is provided.
In a third aspect of the invention, there is provided a throat spray comprising a composition as described above.
The fourth aspect of the invention provides a preparation method of a throat spray, which comprises the following specific steps:
1) heating, stirring and mixing purified water, glycerol and sodium carboxymethylcellulose, and cooling to obtain a first mixed solution;
2) adding polysorbate 80, sodium chloride, sodium edetate, citric acid, sodium citrate and potassium sorbate into the first mixed solution, and stirring and mixing uniformly to obtain the throat spray.
Preferably, the heating temperature in the step 1) is 70-80 ℃, the stirring speed is 250 r/min, the heating and stirring are carried out until the sodium carboxymethyl cellulose is completely dissolved, and the cooling is carried out to 40 ℃.
Preferably, the stirring speed in the step 2) is 250 revolutions per minute, and the stirring time is 10-30 min.
Compared with the prior art, the invention has the beneficial effects that: after the throat spray for relieving the dry mouth and throat is sprayed into the oral cavity or the throat, the throat spray simulates the mucous membrane secretion of the throat of a human body, lubricates and softens the mucous membrane of the oral cavity and the throat, effectively keeps the mucous membrane between the oral cavity and the throat moist, reduces the evaporation of water on the surface of the mucous membrane, creates a relatively moist environment, adopts a physical principle, does not contain medicinal components, has no toxic or side effect on the human body, and is suitable for long-term use.
Detailed Description
The technical solution of the present invention is explained in further detail below.
Example one
The embodiment provides a composition, which comprises the following components in percentage by mass: 802.0% of polysorbate, 15.0% of glycerol, 0.5% of sodium chloride, 0.3% of sodium edetate, 0.3% of citric acid, 0.2% of sodium citrate, 0.2% of sodium carboxymethylcellulose, 0.3% of potassium sorbate and 81.2% of purified water.
The embodiment further provides application of the composition in preparing a medicine for relieving dry mouth and throat.
This example further provides a throat spray comprising the composition described above.
The embodiment further provides a preparation method of the throat spray, which comprises the following steps:
1) heating purified water, glycerol and sodium carboxymethylcellulose to 70-80 ℃, stirring at a speed of 250 revolutions per minute to completely dissolve the sodium carboxymethylcellulose, and cooling to about 40 ℃;
2) adding polysorbate 80, sodium chloride, sodium edetate, citric acid, sodium citrate and potassium sorbate into the mixed solution treated in the step 1), stirring at the speed of 250 revolutions per minute for 10-20 min, and stirring and mixing uniformly.
Example two
The embodiment provides a composition, which comprises the following components in percentage by mass: 803.0% of polysorbate, 20.0% of glycerol, 1.0% of sodium chloride, 0.5% of sodium edetate, 0.2% of citric acid, 0.2% of sodium citrate, 0.1% of sodium carboxymethylcellulose, 0.3% of potassium sorbate and 74.7% of purified water.
The embodiment further provides application of the composition in preparing a medicine for relieving dry mouth and throat.
This example further provides a throat spray comprising the composition described above.
The embodiment further provides a preparation method of the throat spray, which comprises the following steps:
1) heating purified water, glycerol and sodium carboxymethylcellulose to 70-80 ℃, stirring at a speed of 250 revolutions per minute to completely dissolve the sodium carboxymethylcellulose, and cooling to about 40 ℃;
2) adding polysorbate 80, sodium chloride, sodium edetate, citric acid, sodium citrate and potassium sorbate into the mixed solution treated in the step 1), stirring at the speed of 250 revolutions per minute for 10-20 min, and stirring and mixing uniformly.
EXAMPLE III
The embodiment provides a composition, which comprises the following components in percentage by mass: 805.0% of polysorbate, 18.0% of glycerol, 1.0% of sodium chloride, 0.5% of sodium edetate, 0.3% of citric acid, 0.3% of sodium citrate, 0.08% of sodium carboxymethylcellulose, 0.3% of potassium sorbate and 74.52% of purified water
The embodiment further provides application of the composition in preparing a medicine for relieving dry mouth and throat.
This example further provides a throat spray comprising the composition described above.
The embodiment further provides a preparation method of the throat spray, which comprises the following steps:
1) heating purified water, glycerol and sodium carboxymethylcellulose to 70-80 ℃, stirring at a speed of 250 revolutions per minute to completely dissolve the sodium carboxymethylcellulose, and cooling to about 40 ℃;
2) adding polysorbate 80, sodium chloride, sodium edetate, citric acid, sodium citrate and potassium sorbate into the mixed solution treated in the step 1), stirring at the speed of 250 revolutions per minute for 10-20 min, and stirring and mixing uniformly.
The throat sprayer is sprayed into the oral cavity and the pharynx, and can quickly permeate mucous membrane tissues with special protection functions to lubricate and soften the mucous membranes of the pharynx.
Biological evaluation is carried out on stock solution of the throat spray by the inspection center of biological materials and products of Sichuan medical instruments, and the result shows that the cytotoxicity of the stock solution sprayed by the throat spray is less than 2 grade, and the stock solution has no toxicity, sensitization and irritation and has safe and reliable components.
The Shanxi medical quality supervision and inspection institute detects the physical and chemical properties of the throat spray, and each detection result meets the following requirements:
appearance: colorless to pale yellow liquid
pH value: 5-8
Residue on ignition: not more than 2%
Heavy metals: not more than 10 mug/g
The microbial limit: the microbial limit of the throat sprayer meets the requirements of table 1
TABLE 1 throat nebulizer microbial limits
| Total number of aerobic bacteria | Total number of mold and yeast | Staphylococcus aureus | Pseudomonas aeruginosa | Escherichia coli |
| ≤100cfu/ml | ≤10cfu/ml | Cannot be detected | Cannot be detected | Cannot be detected |
Although a plurality of embodiments of the present invention have been described, various changes or modifications may be made by those skilled in the art within the scope of the appended claims, and therefore, the scope of the present invention should not be limited to the claims.
Claims (8)
1. A composition comprising polysorbate 80, glycerin, sodium chloride, sodium edetate, sodium carboxymethylcellulose, citric acid, sodium citrate, potassium sorbate and purified water.
2. The composition according to claim 1, characterized in that, in mass percentages: polysorbate 80 accounts for 2.0-8.0%, glycerin accounts for 10-25%, sodium chloride accounts for 0.3-1.0%, sodium edetate accounts for 0.1-0.8%, sodium carboxymethylcellulose accounts for 0.05-0.3%, citric acid accounts for 0.1-0.5%, sodium citrate accounts for 0.1-0.5%, potassium sorbate accounts for 0.2-0.5%, and purified water accounts for 70-90%.
3. The composition according to claim 2, characterized in that, in mass percentages: 3.0% of polysorbate 80, 15% of glycerin, 0.5% of sodium chloride, 0.3% of sodium edetate, 0.1% of sodium carboxymethylcellulose, 0.2% of citric acid, 0.3% of sodium citrate, 0.3% of potassium sorbate and 81.3% of purified water.
4. Use of a composition according to any one of claims 1 to 3 in the manufacture of a medicament for relieving dry oropharynx.
5. A throat spray comprising a composition according to any of claims 1 to 3.
6. A preparation method of a throat spray is characterized by comprising the following specific steps:
1) heating, stirring and mixing purified water, glycerol and sodium carboxymethylcellulose, and cooling to obtain a first mixed solution;
2) adding polysorbate 80, sodium chloride, sodium edetate, citric acid, sodium citrate and potassium sorbate into the first mixed solution, and stirring and mixing uniformly to obtain the throat spray.
7. The preparation method according to claim 6, wherein the heating temperature in the step 1) is 70-80 ℃, the stirring speed is 250 r/min, the heating and stirring are carried out until the sodium carboxymethyl cellulose is completely dissolved, and the cooling is carried out to 40 ℃.
8. The method according to claim 7, wherein the stirring speed in the step 2) is 250 rpm, and the stirring time is 10 to 30 min.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910530964.XA CN112107543A (en) | 2019-06-19 | 2019-06-19 | Throat spray and its preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910530964.XA CN112107543A (en) | 2019-06-19 | 2019-06-19 | Throat spray and its preparation method |
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| Publication Number | Publication Date |
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| CN112107543A true CN112107543A (en) | 2020-12-22 |
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| CN201910530964.XA Pending CN112107543A (en) | 2019-06-19 | 2019-06-19 | Throat spray and its preparation method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112220699A (en) * | 2019-07-15 | 2021-01-15 | 陕西佰傲再生医学有限公司 | Oral care compositions |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2005139089A (en) * | 2003-11-05 | 2005-06-02 | Sakamoto Yakuhin Kogyo Co Ltd | Feeder for oral cavity moisturizer and oral cavity moisturizer |
| CN102166225A (en) * | 2010-11-29 | 2011-08-31 | 吴克 | Snore stopping liquid and preparation process thereof |
| CN105833278A (en) * | 2016-04-25 | 2016-08-10 | 北京凯莱天成医药科技有限公司 | Composition for treating xerostomia and oral diseases |
-
2019
- 2019-06-19 CN CN201910530964.XA patent/CN112107543A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2005139089A (en) * | 2003-11-05 | 2005-06-02 | Sakamoto Yakuhin Kogyo Co Ltd | Feeder for oral cavity moisturizer and oral cavity moisturizer |
| CN102166225A (en) * | 2010-11-29 | 2011-08-31 | 吴克 | Snore stopping liquid and preparation process thereof |
| CN105833278A (en) * | 2016-04-25 | 2016-08-10 | 北京凯莱天成医药科技有限公司 | Composition for treating xerostomia and oral diseases |
Non-Patent Citations (1)
| Title |
|---|
| 刘茂柏等: "《安全用药指导手册》", 31 August 2013, 厦门大学出版社 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112220699A (en) * | 2019-07-15 | 2021-01-15 | 陕西佰傲再生医学有限公司 | Oral care compositions |
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Application publication date: 20201222 |