CN111956682A - A butyrum-boron cream for treating stomatitis and gingivitis, and its preparation method and application - Google Patents
A butyrum-boron cream for treating stomatitis and gingivitis, and its preparation method and application Download PDFInfo
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- 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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/22—Boron 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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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- A—HUMAN NECESSITIES
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- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Abstract
The invention discloses a butyl boron cream for inflammation such as stomatitis and gingivitis, and a preparation method and application thereof. The butyl boron cream consists of the following raw and auxiliary materials in percentage by weight: 4 to 24 percent of glycerin, 0.4 to 2.4 percent of sodium carboxymethylcellulose, 0.06 to 0.6 percent of saccharin sodium, 0.6 to 6 percent of borax, 0.6 to 6 percent of sodium lauryl sulfate, 30 to 70 percent of calcium carbonate, 0.1 to 2.0 percent of clove basil oil, 0.2 to 2.0 percent of essence and purified water which is added to 100 percent. The invention takes clove basil oil and borax as raw materials, has better bacteriostatic action on common pathogenic bacteria in oral cavity, and comprises staphylococcus aureus, escherichia coli, streptococcus mutans and a plurality of anaerobic bacteria and melanogenesis bacteria. Has antiinflammatory and analgesic effects, and can be used for treating oral diseases such as stomatocace, gingival hemorrhage, red swelling, and abscess caused by stomatitis and gingivitis. The invention has small side effect and definite curative effect.
Description
Technical Field
The invention relates to a butyrum-boron cream for stomatitis, gingivitis and other inflammations, and a preparation method and application thereof, belonging to the technical field of medicines.
Background
Oral diseases are a common frequently encountered disease in humans and include oral ulcer, stomatitis, gingivitis, periodontitis, and the like.
Stomatitis is an inflammation of the oral mucosa and can spread to the buccal mucosa, tongue, gum, palate, etc. It is common in children, especially infants, and can be used for simple onset of disease or secondary to diarrhea, malnutrition, acute infection, and general diseases such as chronic illness and physical weakness. The main causes of stomatitis are bacteria, viruses and fungi. Bacterial infectious stomatitis is often the main pathogenic bacterium of streptococcus and staphylococcus. Under the condition of low body resistance such as acute infection, long-term diarrhea and the like, if the oral cavity is not clean, the bacteria breed in large quantity, thereby causing acute oral mucosa injury. Stomatitis is mainly classified into ulcerative stomatitis, herpetic stomatitis, drug-induced stomatitis, candida stomatitis, and the like.
Oral ulcer, which is generally called as oral cavity inflammation or aphtha in folk, is a local ulcer injury of oral mucosa which is characterized by recurrent attacks, can self-heal and can occur at any part of the oral mucosa. The mucosa of the lips, cheeks, soft palate or gingiva and the like of the oral cavity is common, single or multiple round or oval ulcers with different sizes occur, the surface is covered with a gray or yellow pseudomembrane, the center is sunken, the boundary is clear, the surrounding mucosa is red and slightly swollen, the local burning pain of the ulcer is obvious, and the oral cavity has the characteristics of periodicity, recurrence and self-limitation, the appetite of severe patients can be influenced, and great inconvenience is caused to daily diet. The canker sore is also known as Recurrent Aphthous Stomatitis (RAS), Recurrent Oral Ulcer (ROU), recurrent aphthous ulcer (rohr ahthae) or canker sore. At present, the etiology and pathogenic mechanism of oral ulcer are still unclear. The causes of oral ulcers may be local trauma, stress, changes in food, medication, hormone levels, and vitamin or trace element deficiencies. Systemic diseases, heredity, immunity and microorganisms may play an important role in the development and development of oral ulcers. Because the etiology is unknown, the diagnosis of the oral ulcer is completely based on the medical history and clinical manifestations, and laboratory indexes which can be used as the basis for diagnosis are lacked. Canker sores indicate that the body may have underlying systemic diseases, such as those of the gastrointestinal, blood and endocrine systems, but clinically most patients are healthy and have no systemic disease.
Gingivitis is an acute and chronic inflammation of the gingival tissue, manifested as bleeding, swelling and pain of the gum, which continues to invade the hard tissue and produce periodontitis, including inflammation of the gingival tissue and manifestations of systemic diseases in the gum. Gingivitis is mainly classified into chronic gingivitis, adolescent gingivitis, gestational gingivitis, acute gingivitis, and necrotizing ulcerative gingivitis. Chronic gingivitis, the most common form, is highly prevalent, and almost every person develops chronic gingivitis of varying degrees and extent over a period of life. Plaque build-up on the tooth surface near the gingival margin is the initiating factor for chronic gingivitis, and other factors such as tartar, food impaction, poor restoration, crowding of teeth, mouth breathing, etc. can promote plaque accumulation, causing or aggravating inflammation of the gums. The lesion of gingivitis is limited to gingiva, no deep periodontal tissue is damaged, after local factors are removed, the inflammation of the gingiva fades out after about one week, the damaged collagen fibers can regenerate, the color, shape, quality and function of the gingiva can be completely recovered to be normal, and the prognosis is good. Gingivitis is easily recurrent if the patient does not effectively control the plaque and is regularly reviewed, resulting in a large accumulation of plaque there.
Periodontitis is a chronic inflammation of the periodontal supporting tissue caused primarily by local factors. If gingivitis is not treated timely, inflammation can diffuse from the gingiva to the deep layer to the periodontal ligament, alveolar bone and cementum, and periodontitis can develop. Because early stage has no obvious subjective symptoms and is easy to ignore, the symptoms are serious and even the teeth can not be kept. Thus, the patient must be treated early and timely. Periodontitis is mainly characterized by: periodontal pocket formation, gingival inflammation, alveolar bone resorption, and varying degrees of tooth loosening. A great deal of research suggests that periodontitis is a major cause of tooth loss in humans, and the incidence of periodontitis is particularly high in adolescents and the elderly, and is mainly classified into prepubertal periodontitis, juvenile periodontitis, aggressive periodontitis, adult periodontitis, periodontitis accompanied by systemic diseases, and the like.
Ocimum gratissimum, a plant in the genus of Ocimum, in the form of Ocimum gratissimum L, also known as clove and common rue herb, has a cool and fragrant smell, mainly grows in tropical and subtropical regions, and is cultivated in China, India, Columbia, Benin and other countries. Ocimum gratissimum and essential oil thereof are important flavoring essences and have the capabilities of resisting bacteria, cancers, oxidation, corrosion and radiation. The oleum Ocimi Gratissimi is also important raw material for perfume and cosmetic industry, and can be used for preparing essence for soap, tooth sound, cosmetic, etc. In addition, Ocimum gratissimum has medicinal value, and can be used for treating various diseases, such as headache, fever, cough, upper respiratory infection, pneumonia, bronchitis, ophthalmalgia, conjunctivitis and diarrhea.
The oleum Ocimi Gratissimi has spicy flos Caryophylli-like fragrance and faint scent, is a yellowish to reddish brown liquid at room temperature, is easily soluble in ethanol, ethyl alcohol or glacial acetic acid, and is almost insoluble in water. The oleum Ocimi Gratissimi has eugenol as main ingredient, and has strong bactericidal effect and local antiseptic effect. Moxiaoluo and the like carry out bacteriostasis tests on the Ocimum gratissimum essential oil, and the results show that the Ocimum gratissimum essential oil has obvious inhibition effect on gram-positive bacteria such as bacillus subtilis and the like. Akinmolladin and other researches show that the phenol and aldehyde substances are the chemical components with the highest content in the clove basil essential oil and are accepted antioxidant components. Compared with gallic acid, the antioxidant performance of the Ocimum gratissimum essential oil is found, and the research on the insubstantial difference of the antioxidant performance of 2 substances at high concentration shows that the Ocimum gratissimum essential oil can be used for clinically treating superficial fungal infection. The Ocimum gratissimum essential oil is smeared on the dermatophyte infected parts of the scalp and hands 2 times a day, and an obvious treatment effect is found. The oleum Ocimi Gratissimi and eugenol can directly act on vascular smooth muscle to dilate blood vessel and reduce blood pressure. It also has sleep promoting and analgesic effects. Ocimum gratissimum, a plant used as both medicine and food, has been widely used in the fields of food, medicine and the like.
BoraxSodium tetraborate (Na) as academic name2B4O7·10H2O) is crystal refined by mineral borax. The 'Bencao gang mu' carries that the borax is sweet, slightly mature, cool, warm and nontoxic. Enter lung and stomach meridians. It is mainly used for resolving phlegm and relieving cough, and eliminating obstruction of throat. Borax has effects of clearing away heat and toxic materials, eliminating mass, removing phlegm heat, relieving inflammation, and healing sore. It can be used for treating dysphagia, regurgitation, cough, sore throat, cough with asthma due to lung heat, cough with dyspnea due to excessive phlegm, laryngalgia, hoarseness, and aphtha of the mouth and tongue. It can be used for treating various cancers, especially tongue cancer, esophageal cancer, breast cancer, cervical cancer, and vaginal cancer.
In recent years, a large amount of antibacterial, antifungal and antiviral traditional Chinese medicines are screened, and the borax is found to have an antibacterial effect on common suppurative bacteria such as staphylococcus aureus and the like, and also has an anti-mycobacterium tuberculosis, antifungal and antiviral effect. The culture medium is added with 100g/L borax water solution, and has inhibitory effect on staphylococcus, diplococcus pneumoniae, meningococcus, hemolytic streptococcus, white streptococcus, Escherichia coli, Pseudomonas aeruginosa, Bacillus anthracis, diphtheria bacillus, dysentery bacillus, typhoid bacillus, paratyphoid bacillus, dermatophyte, filamentous fungi, etc. The boron analog has antiinflammatory, antiarthritic, pleuritis resisting and analgesic effects. Similar to the commercial agent indomethacin, it is also an inhibitor of induced edema in rats and mice. Bingpeng powder has antifungal activity, and can inhibit or kill dermatophyte, Candida and Candida albicans. The borax and low-concentration liquefied phenol have disinfection and corrosion prevention effects. Borax has weak bacteriostatic action and is commonly used for mucous membrane disinfection, and 20g/I. -40 g/L solution is used for washing eye conjunctiva, oral cavity and vaginal mucosa. The 10g/L to 20g/L aqueous solution can be used for gargling and treating stomatitis and gingivitis. In medicine, borax is mainly used for treating blepharitis, stomatitis, pharyngitis, tonsillitis, mycotic vaginitis, impregnated foot and other diseases. The compound borax gargle is an over-the-counter medicine in stomatology and is used for oral disinfection and antisepsis of stomatitis, pharyngitis, tonsillitis and the like. The borax-glycerol liniment is used for treating oral mucosa ulcer, and the like, and the borax-glycerol liniment is used for treating oral mucosa ulcer pestilence, and has the total clinical effective rate of 95%.
Chinese patent application publication No. CN101259161A discloses a production process of a cream for treating toothache and gingivitis, which comprises the following steps: mixing glycerol, sodium carboxymethylcellulose and sodium lauryl sulfate in an oil phase kettle, and stirring; heating purified water, borax and saccharin sodium in water phase pot for dissolving; pumping the two phases into an emulsifying pot to be emulsified uniformly to prepare colloid, stirring the colloid and calcium carbonate uniformly in the emulsifying pot, and then putting the balsam, the clove basil oil and the glycyrrhetinic acid ethanol solution into the emulsifying pot to be stirred uniformly to obtain the cream for treating toothache and periodontitis. However, the following disadvantages still exist in this method: 1. the sodium lauryl sulfate used as an anionic surfactant has good wetting, floating, decontamination and foaming performances. The sodium lauryl sulfate is easy to dissolve in water to form a milky solution, but the sodium lauryl sulfate and the oil phase are mixed and dissolved in the method and added before the gum is prepared, so that the sodium lauryl sulfate cannot be fully dissolved and the effect of the foaming agent is exerted. 2. In the method, two phases are emulsified to prepare colloid, the colloid is kept stand for more than 16 hours, and then emulsification, stirring and the like are carried out, so that the process time is long.
Chinese patent application publication No. CN103751032A discloses an anti-inflammatory analgesic toothpaste containing eugenol, borax, potassium lauryl sulfate, calcite powder, sorbitol, glycerin, sodium carboxymethylcellulose, sodium saccharin, and purified water; the components are 6-7 parts of phenol, 22-25 parts of borax, 20-25 parts of potassium dodecyl sulfate, 500 parts of calcite powder 380-. The method comprises the following steps: uniformly stirring and dispersing calcite powder, sorbitol, glycerol, sodium carboxymethylcellulose and sodium saccharin, adding purified water, fully dissolving to form a colloidal solution, and standing; adding phenol, borax and potassium dodecyl sulfate, stirring, and making into paste. However, the following disadvantages still exist in this method: in the method, calcite powder, sorbitol, glycerol, sodium carboxymethylcellulose and sodium saccharin are uniformly stirred and dispersed, and are fully dissolved into a colloidal solution after purified water is added.
Chinese patent application publication No. CN106491722A discloses a butylboron cream for treating oral diseases and a preparation method thereof: the butylboron cream for treating oral diseases and the preparation method thereof comprise the following raw materials in parts by weight: 5 to 20 percent of glycerin, 0.5 to 2 percent of sodium carboxymethylcellulose, 0.1 to 0.5 percent of saccharin sodium, 15 to 35 percent of water, 1 to 5 percent of borax, 1 to 5 percent of sodium dodecyl sulfate, 40 to 65 percent of calcium carbonate, 0.2 to 1.5 percent of clove basil oil and 0.3 to 1.5 percent of menthol; the preparation method comprises the following steps: mixing and stirring glycerol and sodium carboxymethylcellulose under the condition of water bath at 25 ℃ to moisten the sodium carboxymethylcellulose, then adding water, sodium saccharin and borax, stirring uniformly, then adding calcium carbonate and sodium dodecyl sulfate, continuously stirring, standing for 1.5-2h, finally adding clove basil oil and menthol, and stirring uniformly to obtain the butylboron emulsifiable paste. However, the following disadvantages still exist in this method: 1. in the invention, the oil phase is directly added into the water phase after being mixed and stirred, the subsequent process is not emulsified and homogenized, and the solubility and uniformity of the product can influence the quality of the product to a certain extent. So that it cannot exert its medicinal effect sufficiently. 2. The borax is dissolved under the condition of water bath at 25 ℃, and the solubility of the borax is low and the dissolution time is long at the temperature.
In view of the above, the present inventors have proposed a novel method for preparing a cream containing butyrum and boron for treating inflammation such as stomatitis and gingivitis, based on various considerations, by which the problems existing in the prior art can be overcome.
Disclosure of Invention
The invention aims to provide a boron-containing cream for treating inflammations such as stomatitis, gingivitis and the like, and a preparation method and application thereof.
In order to achieve the purpose, the invention adopts the following technical scheme
The invention relates to a butyrum-boron cream for inflammations such as stomatitis and gingivitis, which comprises the following raw and auxiliary materials in percentage by weight: 4 to 24 percent of glycerin, 0.4 to 2.4 percent of sodium carboxymethylcellulose, 0.06 to 0.6 percent of saccharin sodium, 0.6 to 6 percent of borax, 0.6 to 6 percent of sodium lauryl sulfate, 30 to 70 percent of calcium carbonate, 0.1 to 2.0 percent of clove basil oil, 0.2 to 2.0 percent of essence and purified water which is added to 100 percent.
The butyrum-boron cream for treating inflammations such as stomatitis and gingivitis is preferably prepared from the following raw and auxiliary materials in percentage by weight: 8 to 16 percent of glycerin, 0.8 to 2.4 percent of sodium carboxymethylcellulose, 0.08 to 0.4 percent of saccharin sodium, 2 to 6 percent of borax, 2 to 6 percent of sodium lauryl sulfate, 40 to 60 percent of calcium carbonate, 0.2 to 1.5 percent of clove basil oil, 0.3 to 1.5 percent of essence and purified water to make up to 100 percent.
Furthermore, the invention also provides a preparation method of the butyl boron cream for inflammation such as stomatitis, gingivitis and the like, which comprises the following steps:
(1) weighing the raw materials and auxiliary materials according to the weight percentage;
(2) preparing an oil phase: taking glycerol, slowly adding sodium carboxymethylcellulose, stirring for 30 minutes, and uniformly dispersing for later use;
(3) preparing a water phase: heating purified water to 48 + -2 deg.C, slowly adding Borax and sodium saccharin, stirring for 10 min until Borax and sodium saccharin are completely dissolved;
(4) preparing glue: slowly adding the oil phase into the filtered water phase solution, stirring for 30 minutes and preparing for mixing;
(5) mixing and vacuum degassing: slowly adding oleum Ocimi Gratissimi and essence base under stirring, stirring for 30 min and homogenizing for 2 times, sequentially adding calcium carbonate and sodium laurylsulfate, stirring for 90 min, and homogenizing for 3 times to obtain uniform cream; degassing the ointment for 3-4 hours under the vacuum degree of-0.07 MPa +/-0.01 MPa until the ointment has no obvious bubbles, and discharging the ointment;
(6) filling: filling the prepared ointment into a medicinal composite tube to obtain the ointment.
Furthermore, the invention also provides application of the butyl boron cream for treating inflammations such as stomatitis, gingivitis and the like in preparation of medicines for treating inflammations such as stomatitis, gingivitis and the like.
Among them, preferably, the stomatitis includes ulcerative stomatitis, herpetic stomatitis, drug-induced stomatitis, candida stomatitis, etc., and the gingivitis includes inflammation such as chronic gingivitis, adolescent gingivitis, gestational gingivitis, acute gingivitis, necrotizing ulcerative gingivitis, and periodontitis.
Preferably, the butyrum-boron cream for treating inflammations such as stomatitis and gingivitis and the compound chlorhexidine gargle are combined for preparing the medicine for treating the inflammations such as stomatitis and gingivitis.
Compared with the prior art, the invention has the beneficial effects that:
1. the invention takes clove basil oil and borax as raw materials, has better bacteriostatic action on common pathogenic bacteria in oral cavity, including staphylococcus aureus, colon bacillus, streptococcus mutans, and various anaerobic bacteria and melanogenesis bacteria. Has antiinflammatory and analgesic effects, and can be used for treating oral diseases such as stomatocace, gingival hemorrhage, red swelling, and abscess caused by stomatitis and gingivitis. The invention has small side effect and definite curative effect.
2. In the invention, after water phase (borax and saccharin sodium) and oil phase (glycerin and sodium carboxymethylcellulose) are respectively dissolved and stirred, the gum is prepared, and then clove basil oil and essence base are added, and the mixture is stirred and homogenized by a homogenizing and emulsifying machine, so that the drug effect components can be fully and uniformly dispersed in the cream, and the drug effect of the product can be better exerted.
3. The lauryl sodium sulfate is added after the gum is prepared and is dissolved with part of water, so that the paste body has a compact structure, good storage stability, no generation of a large amount of bubbles and easy and complete degassing. Can better exert the decontamination foaming performance.
4. The borax solubilities at different temperatures are greatly different, and the solubilities are 1.6g/100g at 0 ℃, 2.01g/100g at 20 ℃ and 10.6g/100g at 50 ℃. The water phase (borax and saccharin sodium) dissolution temperature of the invention is 48 +/-2 ℃, and at the temperature, the solubility of borax is greatly improved, the dispersibility and uniformity are improved, and the production efficiency is improved.
5. After two phases are prepared and made into glue respectively, the two phases are stirred for 2 to 3 hours and homogenized for 5 times through a homogenizing emulsifying machine, and vacuum degassing is carried out for 3 to 4 hours, so that the traditional standing process is replaced, the process time is shortened, and the product quality and the production efficiency are improved.
6. The use of the butylboron emulsifiable paste can accelerate the healing of the wound surface of the oral ulcer, reduce the bleeding of gum, relieve symptoms such as swelling and aching of gum and the like. The total effective rate reaches 90 percent. The product of the invention is applied and is matched with gargle medicine for use, thus enhancing the treatment effect, improving the cure rate, shortening the treatment course and relieving the pain of patients.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention clearer and more fully describe the technical solutions in the embodiments of the present invention, it is obvious that the described embodiments are 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.
EXAMPLE 1 preparation of a cream containing butyrum and Borax for treating inflammation such as stomatitis and gingivitis
(1) Weighing the following raw and auxiliary materials in parts by weight: 1200g of glycerol, 125g of sodium carboxymethylcellulose, 10g of saccharin sodium, 2800g of purified water, 250g of borax, 250g of lauryl sodium sulfate, 5200g of calcium carbonate, 85g of clove basil oil and 80g of balsam.
(2) Preparing an oil phase: and (3) taking 1200g of glycerol, slowly adding 125g of sodium carboxymethylcellulose, stirring for 30 minutes, and uniformly dispersing for later use.
(3) Preparing a water phase: 2800g of purified water is taken, heated to ensure that the water temperature reaches 48 +/-2 ℃, then 250g of borax and 10g of saccharin sodium are slowly added, stirred for 10 minutes until the borax and the saccharin sodium are completely dissolved for standby.
(4) Preparing glue: the oil phase was slowly added to the filtered aqueous solution, stirred for 30 minutes and ready to mix.
(5) Mixing and vacuum degassing: adding 85g of oleum Ocimi Gratissimi and 80g of essence base slowly while stirring, stirring for 30 min, homogenizing for 2 times, sequentially adding 5200g of calcium carbonate and 250g of sodium laurylsulfate, stirring for 90 min, and homogenizing for 3 times to obtain uniform cream. Degassing the ointment at-0.07 MPa + -0.01 MPa for 3.5 hr until no bubble is formed, and discharging the ointment.
(6) Filling: filling the prepared ointment into a medicinal composite tube to obtain the ointment.
EXAMPLE 2 preparation of a cream containing butyrum and Borax for treating inflammation such as stomatitis and gingivitis
(1) Weighing the following raw and auxiliary materials in parts by weight: 1180g of glycerol, 115g of sodium carboxymethylcellulose, 9g of saccharin sodium, 2832g of purified water, 251g of borax, 260g of lauryl sodium sulfate, 5190g of calcium carbonate, 84g of clove basil oil and 79g of balsam.
(2) Preparing an oil phase: and (3) slowly adding 1180g of glycerol into 115g of sodium carboxymethylcellulose, stirring for 30 minutes, and uniformly dispersing for later use.
(3) Preparing a water phase: 2832g of purified water is taken, heated to ensure that the water temperature reaches 48 +/-2 ℃, then 251g of borax and 9g of saccharin sodium are slowly added, stirred for 10 minutes until the borax and the saccharin sodium are completely dissolved for later use.
(4) Preparing glue: the oil phase was slowly added to the filtered aqueous solution, stirred for 30 minutes and ready to mix.
(5) Mixing and vacuum degassing: adding 84g of clove basil oil and 79g of essence slowly while stirring, stirring for 30 minutes, homogenizing for 2 times, then sequentially adding 5190g of calcium carbonate and 260g of sodium dodecyl sulfate, continuously stirring for 90 minutes, and homogenizing for 3 times to obtain the uniform emulsifiable paste. Degassing the ointment under-0.07 MPa + -0.01 MPa for 4 hr until no bubble is formed, and discharging the ointment.
(6) Filling: filling the prepared ointment into a medicinal composite tube to obtain the ointment.
EXAMPLE 3 preparation of a cream containing Butylboron for treating inflammation such as stomatitis and gingivitis
(1) Weighing the following raw and auxiliary materials in parts by weight: 1220g of glycerol, 130g of sodium carboxymethylcellulose, 11g of saccharin sodium, 2750g of purified water, 248g of borax, 256g of lauryl sodium sulfate, 5220g of calcium carbonate, 83g of clove basil oil and 82g of balsam.
(2) Preparing an oil phase: and (3) slowly adding 1220g of glycerol into 130g of sodium carboxymethylcellulose, stirring for 30 minutes, and uniformly dispersing for later use.
(3) Preparing a water phase: heating 2750g of purified water to 48 +/-2 ℃, slowly adding 248g of borax and 11g of saccharin sodium, and stirring for 10 minutes until the borax and the saccharin sodium are completely dissolved for later use.
(4) Preparing glue: the oil phase was slowly added to the filtered aqueous solution, stirred for 30 minutes and ready to mix.
(5) Mixing and vacuum degassing: slowly adding 83g of oleum Ocimi Gratissimi and 82g of essence base under stirring, stirring for 30 min, homogenizing for 2 times, sequentially adding 5200g of calcium carbonate and 250g of sodium dodecyl sulfate, stirring for 90 min, and homogenizing for 3 times to obtain uniform cream. Degassing the ointment under-0.07 MPa + -0.01 MPa for 4 hr until no bubble is formed, and discharging the ointment.
(6) Filling: filling the prepared ointment into a medicinal composite tube to obtain the ointment.
Example 4 preparation of a cream containing butyrum and Borax for treating stomatitis and gingivitis
(1) Weighing the following raw and auxiliary materials in parts by weight: 1210g of glycerol, 123g of sodium carboxymethylcellulose, 10g of saccharin sodium, 2812g of purified water, 252g of borax, 251g of lauryl sodium sulfate, 5180g of calcium carbonate, 83g of clove basil oil and 79g of balsam.
(2) Preparing an oil phase: and (3) slowly adding 1210g of glycerol into 123g of sodium carboxymethylcellulose, stirring for 30 minutes, and uniformly dispersing for later use.
(3) Preparing a water phase: 2812g of purified water is taken, heated to ensure that the water temperature reaches 48 +/-2 ℃, and then 252g of borax and 10g of saccharin sodium are slowly added, stirred for 10 minutes until the borax and the saccharin sodium are completely dissolved for later use.
(4) Preparing glue: the oil phase was slowly added to the filtered aqueous solution, stirred for 30 minutes and ready to mix.
(5) Mixing and vacuum degassing: slowly adding 83g of oleum Ocimi Gratissimi and 79g of essence while stirring, stirring for 30 min, homogenizing for 2 times, sequentially adding 5180g of calcium carbonate and 251g of sodium dodecyl sulfate, stirring for 90 min, and homogenizing for 3 times to obtain uniform cream. Degassing the ointment under-0.07 MPa + -0.01 MPa for 4 hr until no bubble is formed, and discharging the ointment.
(6) Filling: filling the prepared ointment into a medicinal composite tube to obtain the ointment.
Experimental example 1 Effect of Using Dingbo cream on the treatment Effect of stomatitis and gingivitis
One, general data
1. Subject: randomly selecting 60 patients with stomatitis and gingivitis such as oral ulcer, gingival bleeding, red swelling, and gingival swelling and pain, wherein the average age is 36.52 + -4.50 years, the maximum age is 50 years, and the minimum age is 20 years.
2. Screening criteria
1) Patients with oral ulcer have obvious recurrence rules.
2) Bleeding and swelling of gum
3) Swelling and aching gum patient
3. Judging the index:
the effect is shown: after treatment, the clinical symptoms of the patient disappear completely or improve obviously;
the method has the following advantages: the clinical symptoms of the patients after treatment are improved to a certain extent;
and (4) invalidation: the clinical symptoms of the patients after treatment did not improve or even worsen and were ineffective:
the total effective rate of the treatment is [ (effective case number + obvious case number)/total case number ] × 100%
Second, test method and procedure
1. Test samples: butylboron cream (prepared in example 1), compound chlorhexidine gargle, regular toothpaste.
2. Grouping tests: divided into 3 groups of 20 people each.
Experimental group 1: dingbo cream (prepared in example 1)
Experimental group 2: dingbo cream (prepared in example 1) + Compound Chlorhexidine gargle
Control group: common toothpaste
3. The course of the test treatment is as follows: the treatment course is 4 weeks.
4. The test method comprises the following steps: three groups of patients brush teeth according to the correct tooth brushing method required by oral hygiene organization, gargle after meals and brush teeth in the morning and evening for more than 3 min. Effect alignment after 4 weeks was used.
1) Control group: the ordinary toothpaste is used for brushing teeth for 2 times in the morning and at night.
2) Experimental group 1: teeth were brushed with the butylboron cream (prepared in example 1) 2 times in the morning and evening.
3) Experimental group 2: brushing teeth with the butylboron cream (prepared in example 1), 2 times in the morning and evening, gargling with the compound chlorhexidine gargle for 2-5 minutes daily based on experiment 1, and gargling with clear water
5. The test steps are as follows: the 60 patients were randomly divided into 3 groups, experimental groups 1-2 were administered, experimental group 3 was control, and treatment was performed according to the correct use of each group, and the corresponding records were made.
6. And (3) test results: the wound healing degree, the healing time, the gingival bleeding degree and the pain degree are used as judgment indexes.
Three, result in
1. Comparison of therapeutic Effect in Each group of patients
The treatment effect of each group is compared as shown in the table 1:
TABLE 1 comparison of the therapeutic effects of the groups
Through comparison of treatment effects of the groups, the total treatment effective rate of the experimental group is higher than that of the control group, compared with the experimental group 1, the treatment effect of the experimental group 2 is superior to that of the experimental group 1, and the difference has statistical significance (P is less than 0.05).
2. Comparison of Total relapse rates in groups of patients
The total relapse rates of the patients in each group are compared as shown in table 2:
TABLE 2 comparison of Total relapse rates among groups of patients
| Relapse within 2 months | Relapse within 4 months | Relapse within 6 months | Total relapse Rate | |
| Experimental group 1 | 0/0.00％ | 0/0.00％ | 1/5.00％ | 5.00％ |
| Experimental group 2 | 0/0.00％ | 0/0.00％ | 0/0.00％ | 0.00％ |
| Control group | 1/5.00％ | 2/10.00％ | 2/10.00％ | 25.00％ |
After 6 months of follow-up, the total relapse rate was lower in the patients of experimental group 1 and experimental group 2 than in the patients of the control group (P <0.05), and the relapse rate was relatively lower in experimental group 2 than in experimental group 1.
And (4) conclusion: experiments prove that the butyroberon cream can accelerate the healing of ulcer wound surfaces, reduce gingival bleeding, relieve symptoms such as gingival swelling and pain and the like by using the butyroberon cream for tooth brushing. After the gargle is used for 4 weeks, the total effective rate reaches 90%, the recurrence rate is only 5.00%, and through experimental data comparison, when the tetraborate cream is used for brushing teeth, the compound chlorhexidine gargle is used for gargling, so that the treatment effect can be enhanced, the wound healing speed is accelerated, the cure rate is improved, the treatment course is shortened, and the pain of a patient is relieved.
Claims (5)
1. The butyl boron cream for treating inflammations such as stomatitis and gingivitis is characterized by comprising the following raw and auxiliary materials in percentage by weight: 4 to 24 percent of glycerin, 0.4 to 2.4 percent of sodium carboxymethylcellulose, 0.06 to 0.6 percent of saccharin sodium, 0.6 to 6 percent of borax, 0.6 to 6 percent of sodium lauryl sulfate, 30 to 70 percent of calcium carbonate, 0.1 to 2.0 percent of clove basil oil, 0.2 to 2.0 percent of essence and purified water which is added to 100 percent.
2. The cream of claim 1, which is prepared from the following raw materials (by weight ratio): 8 to 16 percent of glycerin, 0.8 to 2.4 percent of sodium carboxymethylcellulose, 0.08 to 0.4 percent of saccharin sodium, 2 to 6 percent of borax, 2 to 6 percent of sodium lauryl sulfate, 40 to 60 percent of calcium carbonate, 0.2 to 1.5 percent of clove basil oil, 0.3 to 1.5 percent of essence and purified water to make up to 100 percent.
3. A method of preparing a cream of butane boron for inflammation of the oral cavity, gingivitis and the like, according to claim 1 or 2, comprising the following steps:
(1) weighing the raw materials and the auxiliary materials according to the weight percentage of claim 1 or 2;
(2) preparing an oil phase: taking glycerol, slowly adding sodium carboxymethylcellulose, stirring for 30 minutes, and uniformly dispersing for later use;
(3) preparing a water phase: heating purified water to 48 + -2 deg.C, slowly adding Borax and sodium saccharin, stirring for 10 min until Borax and sodium saccharin are completely dissolved;
(4) preparing glue: slowly adding the oil phase into the filtered water phase solution, stirring for 30 minutes and preparing for mixing;
(5) mixing and vacuum degassing: slowly adding oleum Ocimi Gratissimi and essence base under stirring, stirring for 30 min and homogenizing for 2 times, sequentially adding calcium carbonate and sodium laurylsulfate, stirring for 90 min, and homogenizing for 3 times to obtain uniform cream; degassing the ointment for 3-4 hours under the vacuum degree of-0.07 MPa +/-0.01 MPa until the ointment has no obvious bubbles, and discharging the ointment;
(6) filling: filling the prepared ointment into a medicinal composite tube to obtain the ointment.
4. Use of a cream according to claim 1 or 2 for the treatment of inflammation such as stomatitis, gingivitis and the like in the manufacture of a medicament for the treatment of inflammation such as stomatitis, gingivitis and the like.
5. The use of claim 4, wherein the stomatitis comprises ulcerative stomatitis, herpetic stomatitis, drug-induced stomatitis, candida stomatitis, and the like, and the gingivitis comprises inflammation such as chronic gingivitis, adolescent gingivitis, gestational gingivitis, acute gingivitis, necrotizing ulcerative gingivitis, and periodontitis.
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