CN105997862A - Dental ulcer gargle and preparation method thereof - Google Patents
Dental ulcer gargle and preparation method thereof Download PDFInfo
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- CN105997862A CN105997862A CN201610560251.4A CN201610560251A CN105997862A CN 105997862 A CN105997862 A CN 105997862A CN 201610560251 A CN201610560251 A CN 201610560251A CN 105997862 A CN105997862 A CN 105997862A
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- Prior art keywords
- gargarism
- sodium
- oral ulcer
- gargle
- carbomer
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Classifications
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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
-
- 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
- A61K9/08—Solutions
Abstract
The invention relates to the field of medicine preparation, particularly to dental ulcer gargle and a preparation method thereof. The dental ulcer gargle is prepared by mixing the following components: maltodextrin, sodium carboxymethylcellulose, Carbomer, trisodium citrate, saccharin sodium salt, sodium chloride, potassium hydroxide and purified water. The dental ulcer gargle has the benefits that the dental ulcer gargle does not have toxic and side effects on surface wounds of oral mucosa and is non-irritant. With secretion and neutralization of saliva, the dental ulcer gargle in an oral cavity is changed into hydrogel flooding the whole oral cavity, so that a protective membrane is formed on the surface of a dental ulcer, physically covering the wound and relieving the pain caused by the dental ulcer, oral inflammation and tiny wounds caused by dental hoops or false teeth; meanwhile, the hydrogel further has a certain effect of stopping bleeding.
Description
Technical field
The present invention relates to field of medicine preparing technology, be specifically related to a kind of oral ulcer gargarism and preparation side thereof
Method.
Background technology
Oral ulcer is a kind of common frequently-occurring disease, has the characterized of oral mucosal disease, recurrent oral
Ulcer, aphtha are modal oral ulcer, and the sickness rate in crowd is about 20%.Oral ulcer can be sent out
Being born in any age, the ratio that women suffers from this disease is higher, all can occur throughout the year, be characterized in repeatedly sending out
Work, causalgia unbearably, affect patient's normal diet, can also cause multiple complications simultaneously.Most of patients can
Spontaneous recovery, but the state of an illness severe one persistent period is longer, and the feature that there is recurrent exerbation because of it, bring to patient
The biggest misery.
The etiology unknown of oral ulcer, some patients pathogenic factor is with anxiety, wound, smoking cessation, menstruation, food
Thing allergy is relevant.To some degree, it is difficult to be avoided completely the generation of oral ulcer by Drug therapy,
Therefore alleviating pain during oral ulcer outbreak, promoting heals as early as possible has become the direction of dental ulcer treatment.
Filing date: on July 17th, 2015, in the Chinese invention patent of Publication No. CN104940392
Disclosing " a kind of gargarism for treating oral ulcer ", the main component in said preparation is macromolecular complex
The Chinese medicinal components of matter, takes effect slow, unsatisfactory curative effect.
Summary of the invention
The technical problem to be solved is: for a kind of instant effect, eutherapeutic oral ulcer gargarism
And preparation method thereof.
In order to solve above-mentioned technical problem, the technical solution used in the present invention is: provide a kind of oral ulcer to contain
Gargarism, mixes including following component: include that following component mixes: maltodextrin, carboxymethyl
Sodium cellulosate, carbomer, trisodium citrate, saccharin sodium, sodium chloride, potassium hydroxide and purified water.
Preferably, above-mentioned oral ulcer gargarism also includes component: Mint Essence and glycerol.
Preferably, in above-mentioned oral ulcer gargarism, the weight part ratio of described each component is as follows: maltose
Dextrin 1-15 part, sodium carboxymethyl cellulose 0.2-2 part, carbomer 0.5-2 part, trisodium citrate 0.05-2
Part, Mint Essence 0.005-0.01 part, saccharin sodium 0.005-0.01 part, glycerol 0.1-10 part, sodium chloride 0.09-2
Part, potassium hydroxide 0.01-0.5 part and purified water 67-98 part.
Preferably, in above-mentioned oral ulcer gargarism, the component including following mass percent mixes:
Maltodextrin 1-15%, sodium carboxymethyl cellulose 0.2-2%, carbomer 0.5-2%, trisodium citrate
0.05-2%, Mint Essence 0.005-0.01%, saccharin sodium 0.005-0.01%, glycerol 0.1-10%, sodium chloride
0.09-2%, potassium hydroxide 0.01-0.5%, remaining is purified water.
Preferably, in above-mentioned oral ulcer gargarism, the component including following mass percent mixes:
Maltodextrin 15%, sodium carboxymethyl cellulose 2%, carbomer 2%, trisodium citrate 2%, minty note
Essence 0.01%, saccharin sodium 0.01%, glycerol 10%, sodium chloride 2%, potassium hydroxide 0.5%, remaining is pure
Change water.
Another technical scheme of the present invention is for providing the preparation method of a kind of above-mentioned oral ulcer gargarism: bag
Include following steps: maltodextrin, trisodium citrate, Mint Essence, saccharin sodium, glycerol are dissolved in purification
In water, then adding sodium carboxymethyl cellulose, carbomer, then stir to being completely dissolved, control ph is at 3.5-5.5.
The beneficial effects of the present invention is: gained oral ulcer gargarism of the present invention, oral mucosa top layer is created
Covering weave has no side effect, non-stimulated.Owing to saliva secreted in common people oral cavity becomes neutrality, (pH is 6.5
Between 7.5), composition carbomer in this gargarism and maltodextrin surface with substantial amounts of carboxyl, in
Faintly acid, after the carboxyl of such molecular surface is neutralized, the carbomer of high molecular and maltodextrin meeting
It is cross-linked with each other, becomes a kind of hydrogel, be full of whole oral cavity, form protecting film, thing on oral ulcer surface
Reason covers wound, alleviates the micro-incisions caused because of oral ulcer, oral inflammation, tooth set or artificial tooth and is brought
Pain, and the sheaf space macromolecule network structure that this gel is formed in window surface, can be as suction
Attached platelet, promotes the solidification of the oozing of blood of wound surface, therefore has the effect of certain hemostasis.
Detailed description of the invention
By describing the technology contents of the present invention in detail, being realized purpose and effect, give below in conjunction with embodiment
With explanation.
The design of most critical of the present invention is: the oral ulcer gargarism of the present invention is in oral cavity, along with saliva
Secretion and neutralization, it can be made to become a kind of hydrogel, be full of whole oral cavity, on oral ulcer surface
Forming protecting film, physics covers wound, alleviates because of oral ulcer, oral inflammation.
Embodiment 1
A kind of oral ulcer gargarism, including each component of following weight part ratio: maltodextrin 1 part, carboxylic
Sodium carboxymethylcellulose pyce 0.2 part, carbomer 0.5 part, trisodium citrate 0.05 part, Mint Essence 0.005 part,
Saccharin sodium 0.005 part, glycerol 0.1 part, 0.09 part of sodium chloride, potassium hydroxide 0.01 part and purified water 67
Part.
A kind of oral ulcer gargarism, including each component of following weight part ratio: maltodextrin 1-15 part,
Sodium carboxymethyl cellulose 1 part, carbomer 1 part, trisodium citrate 1 part, Mint Essence 0.008 part, sugar
0.008 part of sodium of essence, glycerol 5 parts, 1 part of sodium chloride, potassium hydroxide 0.4 part and purified water 80 parts.
A kind of oral ulcer gargarism, including each component of following weight part ratio: maltodextrin 15 parts, carboxylic
Sodium carboxymethylcellulose pyce 2 parts, carbomer 2 parts, trisodium citrate 2 parts, Mint Essence 0.01 part, saccharin
0.01 part of sodium, glycerol 10 parts, 2 parts of sodium chloride, potassium hydroxide 0.5 part and purified water 98 parts.
A kind of oral ulcer gargarism, the component including following mass percent mixes: maltodextrin
15%, sodium carboxymethyl cellulose 2%, carbomer 2%, trisodium citrate 2%, Mint Essence 0.01%,
Saccharin sodium 0.01%, glycerol 10%, sodium chloride 2%, potassium hydroxide 0.5%, remaining is purified water.
Embodiment 2
The preparation method of the oral ulcer gargarism described in a kind of embodiment 1: comprise the steps: Fructus Hordei Germinatus
Magma essence, trisodium citrate, Mint Essence, saccharin sodium, glycerol are dissolved in purified water, then it is fine to add carboxymethyl
Dimension element sodium, carbomer, then stir to being completely dissolved, and control ph is at 3.5-5.5.
Concrete preparation method is as follows:
By the maltodextrin of dosage, carbomer, sodium carboxymethyl cellulose, trisodium citrate, minty note
Essence, saccharin sodium, glycerol, sodium chloride, potassium hydroxide are soluble in water, stir to be completely dissolved or use heating,
Ultrasonic grade assists dissolution mechanism to promote to dissolve.
Or by Loading sequence exchange: first by maltodextrin, trisodium citrate, Mint Essence, saccharin sodium,
Glycerol, sodium chloride, potassium hydroxide are soluble in water, add the carbomer of dosage, sodium carboxymethyl cellulose,
Stir to being completely dissolved or use heating, the auxiliary dissolution mechanism such as ultrasonic to promote dissolving.
Peristaltic pump or other fill instruments is used to carry out fill.Gained oral ulcer gargarism solution of the present invention has
Having certain viscosity, Packaging Bottle uses the polyethylene with chicken mouth pump (or with pivoted arm, conveniently going deep into oral cavity) to spray
Bottle, easy to use.After embedding, Co-60 is used to carry out irradiation sterilization, sterilizing dose 5-25KgY, irradiation
Rear product is aseptic.
Embodiment 3
Oral ulcer gargarism clinical practice of the present invention:
1, the present embodiment is observed altogether and has been diagnosed as Blood of Patients with Recurrent Oral 92 example, wherein treatment group 46 example,
Matched group 46 example.Male 44 example, women 48 example, 16 to 65 years old ages, average (35.48 ± 5.84)
Year.Two groups of patients there was no significant difference through statistical test in terms of Sex, Age with medical history, has comparability.
So this clinical trial uses the design of random parallel check experiment.Experimenter is randomly divided into test and compares two
Group.
2, inclusion criteria:
1), this clinical trial of voluntary participation, and sign Informed Consent Form.
2) person that, is diagnosed as recurrent oral ulceration (recurrent oral ulceration also known as recurrent aphtha,
Recurrent aphthous stomatitis, recurrent aphtha)---diagnosis basis: " clinical disease diagnosis is according to curing the mark that takes a turn for the better
The PLA General Logistics Department of quasi-China compiles "
Oral ulcer recurrent exerbation, has violent irritating bitterly time serious.
All can occur at any position of oral mucosa, ulcer is circle or oval, under central fovea, it is covered with
Faint yellow cellulose membrane.
Minor aphtha: diameter, 2～4mm, typically can heal in 1～2 week, rear without cicatrix.
Major aphtha: diameter is 5～25mm, and the ulcer time is long, and deeply, without cicatrix after healing.
Herpes sample aphtha: ulcer is little, diameter is 1～2mm, and number is many, and dozens of or more is dispersed in distribution
In any position of mucosa, with common at the bottom of tongue abdomen, mouth.
3) marginal gingivitis or hepertrophic gingivitis patient---diagnosis basis, are made a definite diagnosis: " clinical disease diagnosis is according to controlling
Turn the PLA General Logistics Department of standard China better to compile "
Marginal gingivitis
There is gingival hemorrhage history, but should first get rid of general hemorrhage disease.
Can look into and see that tartar, soft dirt invest facing, if with disclosing agent, then, it is seen that bacterial plaque is attached thereto or tooth
On face, or there are the local factors such as ill fitting prosthesis.
Gum edge, gum nipple congestion and edema, gingival sulcus slightly deepens, and gum color depth is red, and that touches is the most hemorrhage.
As patient body resistance declines, bacterial virulence strengthens, and when certain local factor irritates in addition, can lead
Cause acute gingival abscess.
Hepertrophic gingivitis
Gum nipple, gum edge are the loosest, and gingiva is peony, form the gingival pocket that the depth does not waits, and quality is soft.
A certain position can be confined to, it is possible to involve full mouth.For full mouth gum edge and gum papillary hypertrophy, especially tongue,
Palate side person is it should be noted that get rid of systemic disease.
Having gingival hemorrhage history, when spy is examined, gingiva is the most hemorrhage.
Local factors such as seeing bacterial plaque, tartar, ill fitting prosthesis or appliance can be looked into, it is possible to see upper lip too short,
Nasal meatus blocks and gets used to the patient of mouth breathing.The latter is common in the hypertrophy of maxillary anterior gingiva.
Occasionally have pathological changes involve whole attached gingiva or (with) alveolar bone of tooth neck position and periodontal membrane.
May result in multiple gingival abscess.
4), it is diagnosed as patients with periodontitis---diagnosis basis: " clinical disease diagnosis and curative effect judging standard Hunan
Association of provincial hospital compiles "
The chronic destructive disease of periodontal deeper tissue, common adult, development is very fast.
Long-term local is had to irritate factor, such as tartar, soft dirt, food impaction, ill fitting prosthesis etc..
Gingival papilla, gum edge, attached gingiva is soft, congested, edema, color is dark red, bright, stippling disappears,
Gingiva is the most hemorrhage, gingiva retraction.
Periodontal pocket is formed or has pyorrhea, epithelium attachment to move to root side, and odontoseisis even shifts.
X-ray film shows frontal resorption, and bone splits can be had to be formed.
5) (according to product desired use, only limit is caused by tooth set or artificial tooth, to be diagnosed as traumatic stomatitis person
Micro-incisions)---diagnosis basis: " clinical disease diagnosis is total according to curing improvement standard China PLA
Rear-service department compiles "
The traumatic oral inflammation caused for a long time by tooth set or artificial tooth.
3, exclusion standard:
1. other clinical trials were participated in 3 months.
2. serious other organs disease patient it is associated with.
3. have clear and definite diabetic history and poor blood glucose control person (blood glucose > 10mmol/L), diabetic foot or its
He affects the disease of wound healing.
Used the most in the recent period radiation, hormone, chemotherapy, somatomedin class dressing, immunosuppressant treatment or its
He may affect the experimenter of wound healing treatment means.
5. there are known relevant medicine for external use drug allergy history, Drug abuse history, alcohol intolerance history.
6. the experimenter that physician in view clinical experience is deemed unsuitable for being selected in (such as critical illness person, has suicidal tendency
Person etc.).
7. gestation, purpose gestation or women breast-feeding their children.
Therapeutic Method:
Experimental group uses " the above embodiment of the present invention oral ulcer gargarism ", using method: using method:
Opening dust cover, by nozzle alignment oral cavity, press manual pump, ejection this product is appropriate (no less than 8 times), contains
After gargling 2-3 minute, liquid is spued, every day 4-6 time (rinsing the mouth time and number of times can be increased according to practical situation)；
Matched group uses " compound recipe chlorhexidine oral cavity gargle ", using method: gargle to gargarism with institute, 1-2mins,
Every day 4-6 time.Gargle not in use by other collutory in experimentation；Can not take food in after gargling with collutory.
Judgment criteria:
1. every experimenter expects that the participation persistent period is 5 days；
2. efficiency evaluation standard is: the alleviation degree of oral ulcer or oral cavity wound pain；
3. evaluation methodology: numeral pain scores method ((numerical rating scale, NRS):
Specific practice is: such as table 1, the horizontal line of standardized bar 10cm on paper, with 1cm for interval, incite somebody to action
0-10 is marked on horizontal line respectively；Patient is allowed the weight of pain to be changed into numeral and at horizontal stroke according to feeling
Labelling on line, records the change of pain degree with this.
Table 1
4. curative effect judging standard:
A clinic control: pain disappears, for without (0 point)
B is effective: pain is from weight (7 points-10 points) to light (less than 3 points)
C is effective: pain from weight (7 points-10 points) to (4 points-6 points), or therefrom (4 points-6 points) arrive
Gently (less than 3 points)
D is invalid: and compare before treatment, pain is without improving.
5. evaluation time: before treatment, treatment reaches 3 days, treatment reaches 5 days.
Statistical method: data acquisition SPSS10.0 analyzes software processes, enumeration data X 2 test, meter
Amount data uses t inspection.
Result:
Experimental group is compared with matched group, at the 5th day, the effective percentage of experimental group apparently higher than matched group, two
Group data p ＜ 0.05；Experimental group and the matched group test data sheet of the 5th day are summarized as follows table 2.
Table 2
| Packet | Number of cases | Effective | Effectively | Invalid | Total effective rate (%) |
| Experimental group | 46 | 21 | 23 | 2 | 95.65% |
| Matched group | 46 | 18 | 12 | 16 | 65.21% |
The foregoing is only embodiments of the invention, not thereby limit the scope of the claims of the present invention, every profit
The equivalents made by description of the invention content, or directly or indirectly it is used in relevant technical field,
The most in like manner it is included in the scope of patent protection of the present invention.
Claims (6)
1. an oral ulcer gargarism, it is characterised in that include that following component mixes: Fructus Hordei Germinatus magma
Essence, sodium carboxymethyl cellulose, carbomer, trisodium citrate, saccharin sodium, sodium chloride, potassium hydroxide and pure
Change water.
Oral ulcer gargarism the most according to claim 1, it is characterised in that described oral ulcer contains
Gargarism also includes component: Mint Essence and glycerol.
Oral ulcer gargarism the most according to claim 1, it is characterised in that the weight of described each component
Amount part ratio as follows: maltodextrin 1-15 part, sodium carboxymethyl cellulose 0.2-2 part, carbomer 0.5-2 part,
Trisodium citrate 0.05-2 part, Mint Essence 0.005-0.01 part, saccharin sodium 0.005-0.01 part, glycerol
0.1-10 part, sodium chloride 0.09-2 part, potassium hydroxide 0.01-0.5 part and purified water 67-98 part.
Oral ulcer gargarism the most according to claim 1, it is characterised in that include following quality hundred
The component of mark mixes: maltodextrin 1-15%, sodium carboxymethyl cellulose 0.2-2%, carbomer
0.5-2%, trisodium citrate 0.05-2%, Mint Essence 0.005-0.01%, saccharin sodium 0.005-0.01%,
Glycerol 0.1-10%, sodium chloride 0.09-2%, potassium hydroxide 0.01-0.5%, remaining is purified water.
Oral ulcer gargarism the most according to claim 1, it is characterised in that include following quality hundred
The component of mark mixes: maltodextrin 15%, sodium carboxymethyl cellulose 2%, carbomer 2%,
Trisodium citrate 2%, Mint Essence 0.01%, saccharin sodium 0.01%, glycerol 10%, sodium chloride 2%,
Potassium hydroxide 0.5%, remaining is purified water.
6. the preparation method of the oral ulcer gargarism described in any one of claim 2-5, it is characterised in that
Comprise the steps: to be dissolved in pure by maltodextrin, trisodium citrate, Mint Essence, saccharin sodium, glycerol
Changing in water, then add sodium carboxymethyl cellulose, carbomer, then stir to being completely dissolved, control ph exists
3.5-5.5。
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114377064A (en) * | 2022-03-10 | 2022-04-22 | 江苏益仁堂生物科技有限公司 | Gargle for treating oral ulcer |
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| US20130022670A1 (en) * | 2011-03-04 | 2013-01-24 | Gruenenthal Gmbh | Aqueous Pharmaceutical Formulation of Tapentadol for Oral Administration |
| CN103027891A (en) * | 2012-11-25 | 2013-04-10 | 天津坤健生物制药有限公司 | Acetylcysteine gargle for treating dental ulcers, and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20130022670A1 (en) * | 2011-03-04 | 2013-01-24 | Gruenenthal Gmbh | Aqueous Pharmaceutical Formulation of Tapentadol for Oral Administration |
| CN103027891A (en) * | 2012-11-25 | 2013-04-10 | 天津坤健生物制药有限公司 | Acetylcysteine gargle for treating dental ulcers, and preparation method thereof |
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| CN114377064A (en) * | 2022-03-10 | 2022-04-22 | 江苏益仁堂生物科技有限公司 | Gargle for treating oral ulcer |
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Application publication date: 20161012 |