CN110522714A - A kind of dark plum mouthwash effervescent tablet and preparation method thereof with rush salivary secretion effect - Google Patents
A kind of dark plum mouthwash effervescent tablet and preparation method thereof with rush salivary secretion effect Download PDFInfo
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- CN110522714A CN110522714A CN201910809555.3A CN201910809555A CN110522714A CN 110522714 A CN110522714 A CN 110522714A CN 201910809555 A CN201910809555 A CN 201910809555A CN 110522714 A CN110522714 A CN 110522714A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
- A61K8/0216—Solid or semisolid forms
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
- A61K8/84—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions otherwise than those involving only carbon-carbon unsaturated bonds
- A61K8/86—Polyethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
- A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
- A61K8/9783—Angiosperms [Magnoliophyta]
- A61K8/9789—Magnoliopsida [dicotyledons]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
- A61K8/98—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution of animal origin
- A61K8/987—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution of animal origin of species other than mammals or birds
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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
- A61P31/02—Local antiseptics
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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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q17/00—Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
- A61Q17/005—Antimicrobial preparations
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
- A61K2800/59—Mixtures
- A61K2800/592—Mixtures of compounds complementing their respective functions
Abstract
The present invention provides a kind of with the mouthwash effervescent tablet and preparation method thereof for promoting salivary secretion function.Mouthwash effervescent tablet provided by the invention solves the problems such as relief across clinical mouth parched symptom drug is few, side effect is big, and the bottled mouthwash volume of tradition is inconvenient to carry greatly, and mouthwash Western medicine antipathogenic composition is ineffective.Mouthwash effervescent tablet of the invention uses wet process pressed-disc technique, is prepared by smoked plum extractive, nutgall extractive, sour agent, alkaline agent, filler, corrigent and other effervescent tablet basic accessories.Smoked plum extractive ingredient in mouthwash effervescent tablet of the invention has apparent rush salivary secretion to act on, and the mixing formula of nutgall extractive and smoked plum extractive has excellent inhibiting effect to a variety of pathogenic bacteria of decayed tooth.Mouthwash effervescent tablet of the invention is convenient for carrying, and is highly suitable for xerostomia patient, to the oral health care of the crowds such as the high person of oral cleaning requirement, commercial out of town trip person.
Description
Technical field
The present invention relates to a kind of with the dark plum effervescent tablet for rinsing mouth and preparation method thereof for promoting salivary secretion effect.The invention belongs to
In pharmaceutical technology field.
Background technique
Epidemiological study shows that disease incidence of the xerostomia in crowd is up to 10%-30%, and China about has 2
Hundred million patients.Xerostomia is the unknown multifactorial disease of reason, and the patient of about 70% main suit's dry has the systemic cause of disease.Mouthful
Dry disease causes disease population cheilosis, mucosal burning sensation, the functions such as influence swallows, language, chewing, appetite.Salivary secretion simultaneously subtracts
Mucous membrane resistance is reduced less, and oral cavity flora is caused to be lacked of proper care, secondary candida albicans infection, rampant dental caries tooth, heavy periodontitis etc.
Severe complication influences life in patients.
It is mainly at present cholinomimetic, artificial saliva etc. for the abirritant object of xerostomia.Cholinomimetic is mainly comospore
Graveoline, cevimeline etc..Cholinomimetic has M3 receptor agonism, can be obviously promoted salivary gland salivary secretion, delays
Solve mouth parched symptom.But cholinomimetic adverse reaction is obvious, predominantly miosis, perspiration, nausea, bronchial spasm, pulmonary edema etc..
The problems such as artificial saliva has saliva substitution effect, but there are expensive, inconvenient to carry, poor tastes.Therefore quasi- choline
Medicine, artificial saliva are only applicable to only a few patient with severe symptoms use, and exploitation is safely and effectively suitble to vast light moderate xerostomia patient to make
Oral care product is extremely urgent.
Mainly based on bottled mouthwash, mouthwash can use country's mouthwash applications for multiple daily, be good at present
Oral care product form, however that there are volumes is big for bottled mouthwash, inconvenient to carry, the problems such as access times are few.Using bubble
Rising piece manufacture craft can effectively solve these problems, and mouthwash is made into effervescent tablet, and putting into is disintegratable in 3-5 minutes in water
It is easy to carry with bottled mouthwash than small in size for clarification, transparent mouthwash.Such as application No. is 201610172570.8 states
A kind of preparation method of complex solid effervescent tablet for rinsing mouth of interior patent disclosure；Application No. is 201610860479.5 domestic patents
A kind of quick-release oral care is disclosed to gargle freshening tablet and preparation method thereof；Application No. is 201810710160.3 domestic patents
Also a kind of effervescent tablet for rinsing mouth is disclosed.
But existing mouthwash or effervescent tablet for rinsing mouth are mainly played using metronidazole, chlorhexidine, the gill western medicine compositions such as go out
Bacteriostasis, long-time service mouthfeel is bad, irritation is big, may cause the complication such as mucosa injury, fungal infection.During Chinese medicine is
Magnificent national great treasure-house, many Chinese medicines have the function of outstanding safe rush salivary secretion and inhibit oral cavity pathogen.
The present invention provides a kind of mouthwash effervescent tablets with promotion salivary secretion mainly based on the traditional Chinese medicine, can solve simultaneously
Xerostomia alleviation drug is undesirable, and mouthwash is inconvenient to carry, and mouthwash Western medicine antipathogenic composition has the problems such as side effect.
Smoked plum extractive: dark plum contains citric acid, malic acid, succinic acid, tartaric acid and oleanolic acid etc., anti-with wide spectrum
Bacterium effect, can inhibit the growth of oral cavity harmful bacteria, help out.Citric acid, that is, citric acid especially contained by dark plum is
A kind of salivary stimulant can be ptyalized by sense of taste reflex irritation patient's salivary gland, to play the work for alleviating dry
With.
Nutgall extractive: Chinese gall has good anti-dental caries effect, and main component is water-disintegrable tannin and galla turcica
Tannic acid has the characteristic in conjunction with calcium and albumen, can inhibit the growth of the cariogenic bacterias such as streptococcus mutans, staphylococcus aureus, subtract
The aggregation of few plaque inhibits glucosyl transferase activity, and then influences cariogenic bacteria growth.
Summary of the invention
The purpose of the present invention is to provide a kind of with the mouthwash effervescent tablet and preparation method thereof for promoting salivary secretion effect.
Solving xerostomia, to alleviate drug few, is only applicable to patient with severe symptoms's use, and traditional mouthwash is inconvenient to carry, antibacterial effect
The problems such as fruit is bad.
In order to achieve the above object, present invention employs following technical solutions:
Of the invention is a kind of with the dark plum mouthwash effervescent tablet for promoting salivary secretion effect, is by the raw material of following parts by weight
It is made: sour agent 25-30 parts by weight, alkaline agent 18-23 parts by weight, adhesive 1.5-2.5 parts by weight, lubricant 2-7 parts by weight, sweet taste
Agent 0.5-1.5 parts by weight, disintegrating agent 0.1-1 parts by weight, corrigent 0.2-0.5 parts by weight, filler 15-30 parts by weight, anti-corrosion
Agent 0.01-0.06 parts by weight, smoked plum extractive 15-25 parts by weight and nutgall extractive 5-10 parts by weight.
Wherein, it is preferred that the dark plum mouthwash effervescent tablet is made of raw material from the following weight: sour 25 weight of agent
Part, 20 parts by weight of alkaline agent, 2 parts by weight of adhesive, 5 parts by weight of lubricant, 1 parts by weight of sweetener, 0.2 parts by weight of disintegrating agent are rectified
0.2 parts by weight of taste agent, 19 parts by weight of filler, 0.05 parts by weight of preservative, 25 parts by weight of smoked plum extractive and Chinese gall mention
Take 5 parts by weight of object.
Wherein, it is preferred that the sour agent be one of citric acid, tartaric acid, fumaric acid, adipic acid or malic acid or
It is a variety of, it is preferred that the acid agent is the mixture of citric acid and tartaric acid, it is furthermore preferred that the weight ratio of citric acid and tartaric acid
Example is (4-6): 1；
Wherein, it is preferred that the alkaline agent is one in sodium carbonate, sodium bicarbonate, potassium carbonate, saleratus or calcium carbonate
Kind is a variety of, it is preferred that the alkaline agent is sodium carbonate.
Wherein, it is preferred that the adhesive is polyvinylpyrrolidone or ethyl alcohol, it is preferred that described adhesive is poly-
Vinylpyrrolidone.
Wherein, it is preferred that the lubricant is Macrogol 6000.
Wherein, it is preferred that the sweetener is one of Aspartame, steviol glycoside or Radix Glycyrrhizae or a variety of, preferably
, the sweetener is steviol glycoside.
Wherein, it is preferred that the disintegrating agent is one of dried starch, sodium carboxymethyl starch or cross-linked pvp or a variety of,
Preferably, the disintegrating agent is cross-linked pvp；
Wherein, it is preferred that one in the corrigent peppermint oil, menthol, artificial vanilla, cortex cinnamomi or various fruit flavor agents
Kind is a variety of, it is preferred that the corrigent is peppermint oil；
Wherein, it is preferred that the filler be one of lactose, mannitol, sucrose, glucose or a variety of, preferably
, the filler is mannitol；
Wherein, it is preferred that the preservative is potassium sorbate or lysozyme, it is preferred that the preservative is sorbic acid
Potassium.
Wherein, it is preferred that the smoked plum extractive specification is 10:1, and nutgall extractive specification is 10:1, and dark plum mentions
Taking the ratio of object and nutgall extractive is (4-5): 1.
Further, the present invention also provides a kind of method for preparing the dark plum mouthwash effervescent tablet, including it is following
Step:
1) raw material is distinguished into ground 100-200 mesh, and weighed by the parts by weight, it is spare；
2) sour agent, smoked plum extractive, disintegrating agent, sweetener are obtained into the first granule through wet granulation and drying；
3) alkaline agent, nutgall extractive, corrigent are obtained into the second granule through wet granulation and drying；
4) by the first granule, the second granule, filler, adhesive, lubricant, preservative are uniformly mixed, are pressed
Piece obtains mouthwash effervescent tablet；
When tableting pressure is excessive, cause the piece hardness of compacting excessive, disintegration time is too long；When tableting pressure is too small,
Cause the piece hardness of compacting too small, although disintegration time is short, is easily broken.When the tableting pressure of tablet is in 4-5kg, institute
The piece compact and smooth obtained, existing preferable disintegration rate are not allowed easily broken yet.It is preferred, therefore, that the tableting pressure of tablet is
4-5kg。
Method flow diagram such as Fig. 1 institute with the dark plum mouthwash effervescent tablet for promoting salivary secretion effect of the present invention
Show.
Further, promote salivary secretion work the invention also provides the dark plum mouthwash effervescent tablet has in preparation
With, alleviate xerostomia mouthwash in application.
Compared to the prior art, the beneficial effects of the present invention are:
1, mouthwash effervescent tablet provided by the invention has outstanding promotion salivary secretion effect, containing gargling one minute
Increase by 1.5 times of Healthy People salivary secretion amount, xerostomia patient's mouth parched symptom is relieved.Compared to cholinomimetic and artificial saliva
Safely and effectively, cheap, it is suitble to the common oral care of xerostomia patient.
2, mouthwash effervescent tablet provided by the invention uses effervescent tablet manufacture craft, solves bottled mouthwash and carries not side
Just the problem of, can will be disintegrated rapidly in effervescent tablet investment 50ml clear water of the invention for clear mouthwash in 3 minutes, make
It is used with the business people frequently to go on business conveniently, is able to satisfy.
3, mouthwash effervescent tablet provided by the invention has outstanding bacteriostasis, especially becomes to a variety of pathogenic bacteria of decayed tooth
The streptococcic inhibiting rate of shape reaches 100%, and more preferably compared to Western medicine antipathogenic composition mouthfeel, side effect is less.
Detailed description of the invention
Fig. 1 is the method flow for preparing the dark plum mouthwash effervescent tablet of the present invention for having and promoting salivary secretion effect
Figure.
Specific embodiment
Embodiment of the present invention is specifically described below in conjunction with example, it should be understood that once embodiment is only
For illustrating the present invention, and it should not be construed as limiting the scope of the invention.
Embodiment 1 promotees the preparation of the dark plum effervescent tablet for rinsing mouth of salivary secretion
1) promote salivary secretion dark plum effervescent tablet for rinsing mouth, be made of raw material from the following weight: 20 parts by weight of lemon acid, 5 weights
Measure part tartaric acid, 20 parts by weight sodium carbonate, 2 weight account polyethylene pyrrolidones, 5 parts by weight Macrogol 6000s, 1 parts by weight sweet tea
Synanthrin glycosides, 0.2 parts by weight cross-linked pvp, 0.2 parts by weight peppermint oil, 19 parts by weight mannitol, 0.05 parts by weight potassium sorbate, 25
Parts by weight smoked plum extractive and 5 parts by weight nutgall extractives.
2) it by ground 160 mesh of above-mentioned raw materials, and weighs by the parts by weight, it is spare.
3) citric acid, tartaric acid, smoked plum extractive, cross-linked pvp, steviol glycoside are uniformly mixed, is added to 70%v/v's
Wet granulation in ethanol solution, and in 50 DEG C of at a temperature of drying, obtain the first granule.
4) by sodium carbonate, nutgall extractive, peppermint oil, it is added to wet granulation in the ethanol solution of 70%v/v, and
It is dry at a temperature of 50 DEG C, obtain the second granule.
5) by the first granule, the second granule, mannitol, polyvinylpyrrolidone, Macrogol 6000, potassium sorbate
It is uniformly mixed, control pressure is that 4-5kg carries out tabletting, obtains mouthwash effervescent tablet.
Embodiment 2 promotees the preparation of the dark plum effervescent tablet for rinsing mouth of salivary secretion
1) promote salivary secretion dark plum effervescent tablet for rinsing mouth, be made of raw material from the following weight: 25 parts by weight of lemon acid, 5 weights
Measure part fumaric acid, 22 parts by weight sodium carbonate, 1.5 weight account polyethylene pyrrolidones, 3.5 parts by weight Macrogol 6000s, 1.5 weights
Measure part steviol glycoside, 0.3 parts by weight cross-linked pvp, 0.3 parts by weight peppermint oil, 15 parts by weight mannitol, 0.06 parts by weight sorbic acid
Potassium, 20 parts by weight smoked plum extractives and 5 parts by weight nutgall extractives.
2) it by ground 170 mesh of above-mentioned raw materials, and weighs by the parts by weight, it is spare.
3) citric acid, fumaric acid, smoked plum extractive, cross-linked pvp, steviol glycoside are uniformly mixed, is added to 70%v/v's
Wet granulation in ethanol solution, and in 45 DEG C of at a temperature of drying, obtain the first granule.
4) by sodium carbonate, nutgall extractive, peppermint oil, it is added to wet granulation in the ethanol solution of 70%v/v, and
It is dry at a temperature of 45 DEG C, obtain the second granule.
5) by the first granule, the second granule, mannitol, polyvinylpyrrolidone, Macrogol 6000, potassium sorbate
It is uniformly mixed, control pressure is that 4-5kg carries out tabletting, obtains mouthwash effervescent tablet.
Embodiment 3 promotees the preparation of the dark plum effervescent tablet for rinsing mouth of salivary secretion
1) promote salivary secretion dark plum effervescent tablet for rinsing mouth, be made of raw material from the following weight: 18 parts by weight of lemon acid, 4.5
Parts by weight tartaric acid, 18 parts by weight sodium carbonate, 2.5 weight account polyethylene pyrrolidones, 4.5 parts by weight Macrogol 6000s, 1 weight
Measure part steviol glycoside, 0.2 parts by weight cross-linked pvp, 0.3 parts by weight peppermint oil, 20 parts by weight mannitol, 0.05 parts by weight sorbic acid
Potassium, 26 parts by weight smoked plum extractives, 6 parts by weight nutgall extractives.
2) it by ground 140 mesh of above-mentioned raw materials, and weighs by the parts by weight, it is spare.
3) citric acid, tartaric acid, smoked plum extractive, cross-linked pvp, steviol glycoside are uniformly mixed, is added to 70%v/v's
Wet granulation in ethanol solution, and in 55 DEG C of at a temperature of drying, obtain the first granule.
4) by sodium carbonate, nutgall extractive, peppermint oil, it is added to wet granulation in the ethanol solution of 70%v/v, and
It is dry at a temperature of 55 DEG C, obtain the second granule.
5) by the first granule, the second granule, mannitol, polyvinylpyrrolidone, Macrogol 6000, potassium sorbate
It is uniformly mixed, control pressure is that 4-5kg carries out tabletting, obtains mouthwash effervescent tablet.
Embodiment 4 promotees the preparation of the dark plum mouthwash effervescent tablet of salivary secretion
1) promote salivary secretion dark plum effervescent tablet for rinsing mouth, be made of raw material from the following weight: 25 weight of apple acid, 5 weights
Measure part fumaric acid, 20 parts by weight sodium bicarbonates, 1.5 weight account polyethylene pyrrolidones, 5 parts by weight Macrogol 6000s, 1 weight
Part Aspartame, 0.5 parts by weight sodium carboxymethylcellulose, 0.2 parts by weight menthol, 20 parts by weight of sucrose, 0.05 parts by weight mountain
Potassium sorbate, 20 parts by weight smoked plum extractives and 5 parts by weight nutgall extractives.
2) it by ground 160 mesh of above-mentioned raw materials, and weighs by the parts by weight, it is spare.
3) malic acid, fumaric acid, smoked plum extractive, sodium carboxymethylcellulose, Aspartame are uniformly mixed, is added to
Wet granulation in the ethanol solution of 70%v/v, and in 50 DEG C of at a temperature of drying, obtain the first granule.
4) by sodium carbonate, nutgall extractive, menthol, it is added to wet granulation in the ethanol solution of 70%v/v, and
It is dry at a temperature of 50 DEG C, obtain the second granule.
5) the first granule, the second granule, sucrose, polyvinylpyrrolidone, Macrogol 6000, potassium sorbate are mixed
It closes uniformly, control pressure is that 4-5kg carries out tabletting, obtains mouthwash effervescent tablet.
Embodiment 5 promotees the preparation of the dark plum mouthwash effervescent tablet of salivary secretion
1) promote salivary secretion dark plum effervescent tablet for rinsing mouth, be made of raw material from the following weight: 25 weight of apple acid, 5 weights
Measure part fumaric acid, 18 pbw of potassium carbonate, 1.5 weight account polyethylene pyrrolidones, 5 parts by weight Macrogol 6000s, 1 parts by weight
Aspartame, 1 parts by weight dried starch, the artificial vanilla of 0.5 parts by weight, 30 parts by weight of lactose, 0.03 parts by weight lysozyme, 15 weight
Part smoked plum extractive and 10 parts by weight nutgall extractives.
2) it by ground 160 mesh of above-mentioned raw materials, and weighs by the parts by weight, it is spare.
3) malic acid, fumaric acid, smoked plum extractive, dried starch, Aspartame are uniformly mixed, is added to 70%v/v's
Wet granulation in ethanol solution, and in 45 DEG C of at a temperature of drying, obtain the first granule.
4) by potassium carbonate, nutgall extractive, artificial vanilla, it is added to wet granulation in the ethanol solution of 70%v/v, and
In 45 DEG C of at a temperature of drying, the second granule is obtained.
5) the first granule, the second granule, lactose, polyvinylpyrrolidone, Macrogol 6000, potassium sorbate are mixed
It closes uniformly, control pressure is that 4-5kg carries out tabletting, obtains mouthwash effervescent tablet.
The influence of 1 hardness of experimental example and PEG-6000 content for mouthwash effervescent tablet appearance
According to the method for embodiment 1, studying different hardness and PEG-6000 dosage has obviously mouthwash effervescent tablet appearance
It influences, is specifically shown in following Tables 1 and 2.It is 4-5kg range, PEG-6000 3%- that pressure should all be controlled in every embodiment
5%.
1 different hardness effervescent tablet of table compares
The effect of 2 various dose PEG-6000 of table
Influence of the 2 dark plum mouthwash effervescent tablet of experimental example to normal adults salivary secretion
1) general information: collection Harbin Medical University student enrollment 20, the age 18-25 years old, male to female ratio 1:
1。
2) it is included in standard: (1) without mouth disease (3) informed consent before assessment is intervened without xerostomia symptom (2) before intervening
It has signed.
3) experimental group: by it is provided by the invention have promote salivary secretion mouthwash effervescent tablet (preparation of embodiment 1) with
The ratio of every 50ml clear water is made into mouthwash, and uses within 6 hours.
4) control group: the clear water of equivalent
5) subject being included in: being carried out xerostomia sense by detection method in three times and salivary secretion increases the sense organ of effect
Evaluation, the specific operation method is as follows: subject evaluates xerostomia sense 1 hour fasting for solids and liquids before evaluation；It is clear to give subject
Water is gargled 1 minute, evaluates xerostomia sense after 10 minutes and salivary secretion increases sense；Interval 10 minutes, it is pre- to give subject
The mouthwash first configured evaluates xerostomia sense after 10 minutes and salivary secretion increases sense containing gargling 1 minute.It evaluates three times above
Subject carries out marking evaluation according to following evaluation criteria according to its oral cavity sensory experience:
<xerostomia sense evaluation criteria>
1 point: feeling strong dry, it is difficult to endure, be badly in need of drinking water
2 points: feeling obvious dry, but still restrain oneself, it is desirable to drink water
3 points: feeling slightly dry, can drink water
4 points: can neither say that feeling that dry can not be said feels that oral cavity is wet, can drink water or not drink water
5 points: feeling that oral cavity is wet, be not required to drink water
6 points, feels that obvious oral cavity is wet, be not desired to drink water
<salivary secretion increases sense evaluation criteria>
1 point: feeling that salivary secretion does not increase
2 points: feeling that salivary secretion slightly increases
3 points: feeling that salivary secretion has increase
4 points: feeling that salivary secretion obviously increases
5 points: feeling that salivary secretion dramatically increases
6 points: feeling that obvious salivary secretion is vigorous
6) result:
After water inlet feed 1 hour, most subjects feel apparent mouthfeel symptom；Xerostomia after being gargled using clear water
Sense is not obviously improved, and it is unobvious that salivary secretion increases sense；After mouthwash of the invention, xerostomia symptom is obvious
Alleviate, it is obvious that salivary secretion increases sense.Concrete outcome is shown in Table 3, table 4.
The scoring of the different dry prognosis xerostomia sense three times of table 3 is compared
4 clear water of table is gargled to be compared with the scoring of mouthwash salivary secretion increase sense
Claims (10)
1. a kind of with the dark plum mouthwash effervescent tablet for promoting salivary secretion effect, it is characterised in that by the raw material system of following parts by weight
At: sour agent 25-30 parts by weight, alkaline agent 18-23 parts by weight, adhesive 1.5-2.5 parts by weight, lubricant 2-7 parts by weight, sweetener
0.5-1.5 parts by weight, disintegrating agent 0.1-1 parts by weight, corrigent 0.2-0.5 parts by weight, filler 15-30 parts by weight, preservative
0.01-0.06 parts by weight, smoked plum extractive 15-25 parts by weight and nutgall extractive 5-10 parts by weight.
2. dark plum mouthwash effervescent tablet as described in claim 1, it is characterised in that be made of raw material from the following weight: sour agent
25 parts by weight, 20 parts by weight of alkaline agent, 2 parts by weight of adhesive, 5 parts by weight of lubricant, 1 parts by weight of sweetener, 0.2 weight of disintegrating agent
Part, 0.2 parts by weight of corrigent, 19 parts by weight of filler, 0.05 parts by weight of preservative, 25 parts by weight of smoked plum extractive and five times
5 parts by weight of seed extract.
3. dark plum mouthwash effervescent tablet as claimed in claim 1 or 2, it is characterised in that the sour agent is citric acid, winestone
One of acid, fumaric acid, adipic acid or malic acid are a variety of, it is preferred that the acid agent is the mixing of citric acid and tartaric acid
Object, it is furthermore preferred that the weight ratio of citric acid and tartaric acid is (4-6): 1；
The alkaline agent is one of sodium carbonate, sodium bicarbonate, potassium carbonate, saleratus or calcium carbonate or a variety of, it is preferred that
The alkaline agent is sodium carbonate.
4. dark plum mouthwash effervescent tablet as claimed in claim 1 or 2, it is characterised in that the adhesive is polyvinyl pyrrole
Alkanone or ethyl alcohol, it is preferred that described adhesive is polyvinylpyrrolidone.
5. dark plum mouthwash effervescent tablet as claimed in claim 1 or 2, it is characterised in that the lubricant is polyethylene glycol
6000。
6. dark plum mouthwash effervescent tablet as claimed in claim 1 or 2, it is characterised in that the sweetener be Aspartame,
One of steviol glycoside or Radix Glycyrrhizae are a variety of, it is preferred that the sweetener is steviol glycoside.
7. dark plum mouthwash effervescent tablet as claimed in claim 1 or 2, it is characterised in that the disintegrating agent is dried starch, carboxylic
One of methyl starch sodium or cross-linked pvp are a variety of, it is preferred that the disintegrating agent is cross-linked pvp；
One of described corrigent peppermint oil, menthol, artificial vanilla, cortex cinnamomi or various fruit flavor agents are a variety of, it is preferred that
The corrigent is peppermint oil；
The filler is one of lactose, mannitol, sucrose, glucose or a variety of, it is preferred that the filler is sweet
Reveal alcohol；
The preservative is potassium sorbate or lysozyme, it is preferred that the preservative is potassium sorbate.
8. dark plum mouthwash effervescent tablet as described in claim 1, it is characterised in that the smoked plum extractive specification is 10:1,
Nutgall extractive specification is 10:1, and the ratio of smoked plum extractive and nutgall extractive is (4-5): 1.
9. a kind of method for preparing the described in any item dark plum mouthwash effervescent tablets of claim 1-8, which is characterized in that including with
Lower step:
1) raw material is distinguished into ground 100-200 mesh, and weighed by the parts by weight, it is spare；
2) sour agent, smoked plum extractive, disintegrating agent, sweetener are obtained into the first granule through wet granulation and drying；
3) alkaline agent, nutgall extractive, corrigent are obtained into the second granule through wet granulation and drying；
4) by the first granule, the second granule, filler, adhesive, lubricant, preservative are uniformly mixed, carry out tabletting, i.e.,
Mouthwash effervescent tablet is made；
Wherein, it is preferred that the tableting pressure of tablet is 4-5kg.
Promote salivary secretion effect 10. the described in any item dark plum mouthwash effervescent tablets of claim 1-8 have in preparation, alleviate mouth
Application in the mouthwash of chamber xerosis.
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