CN105561289B - It is a kind of for treating the pharmaceutical preparation of canker sore - Google Patents
It is a kind of for treating the pharmaceutical preparation of canker sore Download PDFInfo
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- CN105561289B CN105561289B CN201510301385.XA CN201510301385A CN105561289B CN 105561289 B CN105561289 B CN 105561289B CN 201510301385 A CN201510301385 A CN 201510301385A CN 105561289 B CN105561289 B CN 105561289B
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Abstract
It is a kind of for treating the pharmaceutical preparation of canker sore the purpose of the present invention is disclosing.I.e. using alanyl glutamine as the canker sore topical gel formulation of main ingredient ingredient; the characteristics of said preparation be can mitigate rapidly affected part pain, it is curative for effect and the skin surface protection surface of a wound can be adhered to for a long time, slow release drug, irritation is small, biocompatibility is good and have take into account dental ulcer treatment, immunological regulation, prevention are recurred and are integrated, patient's preservation easy to use that is easy to carry about with one, cheap.
Description
The present patent application be the applying date be on 08 27th, 2013, application No. is 2013103755827 divisions
Application.
Technical field
The present invention relates to field of pharmaceutical preparations, specifically a kind for the treatment of recurrence containing alanyl glutamine (Ala-Gln)
The bioadhesive preparation of property canker sore.
Background technique
Recurrent oral ulceration by limitation stomatocace, pain, recurrent exerbation, it is touching it is refractory characterized by, be most
Common diseases of oral mucosa, the disease incidence of general population are about 20% or so.Patient is usually given in the severe pain due to caused by the disease
Considerable distress and inconvenience are brought, and rises one after another, is continuous throughout the year, patients ' life quality is seriously affected, therefore is directed to the prevention of the disease
There is important clinical value with Therapy study.
The common drug of the clinical treatment disease is varied, covers antibiotics, steroids, analgesic class, corrosivity
Class, digestive system class, biological products class, vitamin medicaments and various Chinese medicines, there are also a large amount of civil folk prescription, secret recipes etc..
Although these drugs have certain curative effect, there are many deficiencies: broad-spectrum antibiotic and chemical synthesis antimicrobial are used for a long time
While, also destroy the microbial balance in oral cavity；Hormone medicine should try to control within 1 week using the time, the time
The too long inhibition that may lead hypothalamus-pituitary-adrenal axis, and local immunity can be further decreased and cause to recur；It is rotten
Corrosion drug local irritation is stronger, it is also possible to which the vomiting reflex that can inhibit patient will prevent food and water to be strayed into feed
Respiratory tract.Therefore use is extremely inconvenient；Although biological products such as basic fibroblast growth factor preparation is cured in promotion ulcer
It is curative for effect in terms of closing and relieving pain, it is the generally acknowledged choice drug of current medical circle of oral cavity.But it is expensive, needs low temperature cold
Hiding, is not easy to patient and voluntarily carries, uses and save；The above drug to oral cavity ulcer recurrence and frequent effect almost without
Effect, limits its clinical application to a certain extent.
Summary of the invention
The purpose of the present invention is being directed to the deficiency of existing preparation, develop a kind of using alanyl glutamine as main ingredient ingredient
The characteristics of canker sore topical gel formulation, said preparation is can to mitigate affected part pain, curative for effect and energy rapidly for a long time
It is adhered to the skin surface protection surface of a wound, slow release drug, irritation is small, biocompatibility is good and with taking into account canker sore
Treatment, immunological regulation, prevention recurrence are integrated, patient's preservation easy to use that is easy to carry about with one, cheap.
The technical solution adopted to achieve the purpose of the present invention is as follows:
A kind of preparation method of alanyl glutamine bioadhesive preparation, composition and ratio are as follows: alanyl glutamy
5 ~ 10 parts of amine, 0.02 ~ 0.05 part of Sodium Gualenate, 5 ~ 10 parts of tea polyphenols, 5 ~ 10 parts of allantoin, 1 ~ 2 part of menthol, high-molecular gel
1 ~ 25 part of material, 0.1 ~ 5 part of bioadhesive polymer；
Its prepare the following steps are included:
1) it disperses bioadhesive polymer in water for injection, adds Macromolecule glue material；Or by Macromolecule glue material
Material is added in water for injection, adds bioadhesive polymer；No matter it is added in what order, obtains mixture；
2) alanyl glutamine, Sodium Gualenate, tea polyphenols, allantoin and menthol are added to the mixed of step 2 acquisition
It closes in object, it is to be dissolved complete, that is, obtain product.
Preferably, in the composition and ratio further include: 1 ~ 15 part of macromolecule filming material；Between step 1) starts,
Macromolecule filming material first is added into the water for injection.
That is composition and ratio are as follows: 5 ~ 10 parts of alanyl glutamine, 0.02 ~ 0.05 part of Sodium Gualenate, 5 ~ 10 parts of tea polyphenols,
5 ~ 10 parts of allantoin, 1 ~ 2 part of menthol, 1 ~ 25 part of Macromolecule glue material, 0.1 ~ 5 part of bioadhesive polymer, macromolecule filming material
1 ~ 15 part of material；
Its prepare the following steps are included:
1) macromolecule filming material is dissolved in water for injection, it is made sufficiently to dissolve or be swollen；Obtain mixture system
2) Macromolecule glue material is dissolved in step 1) system obtained, it is made sufficiently to dissolve or be swollen；Coagulated
Colloid system；
3) it then disperses bioadhesive polymer in step 2 gel rubber system obtained, stands, it is made to be uniformly dispersed；Value
Must illustrate, step 2 and 3 sequence it is interchangeable；Obtain new solution system；
4) that alanyl glutamine, Sodium Gualenate, tea polyphenols, allantoin and menthol are added to step 3) is obtained
It is to be dissolved complete in system, that is, obtain product.Preferably, Macromolecule glue material is poloxamer188, chitosan or poly-
The block copolymer of ethylene glycol and its ester.
Preferably, bioadhesive polymer is hypromellose, carbomer or Sodium Hyaluronate.
Preferably: macromolecule filming material is polyethylene kind, PP type, cellulose family or natural macromolecular material.
Using the preparation method alanyl paddy obtained of alanyl glutamine bioadhesive preparation described above
Glutamine bioadhesive formulation products, i.e. alanyl glutamine bioadhesive preparation.
Above-mentioned alanyl glutamine bioadhesive preparation is used to prepare the drug for the treatment of recurrent oral ulceration.The medicine
In product, alanyl glutamine is main ingredient, and Sodium Gualenate, tea polyphenols, allantoin, menthol are compound ingredient.I.e. the present invention is public
The alanyl glutamine bioadhesive formulation products opened can be used as treatment recurrent oral ulceration drug.When necessary, this
In a little drugs other than alanyl glutamine, also there is one or more pharmaceutically acceptable auxiliary materials, carrier etc..With this
The disclosed alanyl glutamine bioadhesive formulation products of invention are for mainly passing through when treating recurrent oral ulceration
Oral cavity partial is smeared or is pasted, and the agent such as gelling agent, paste, paste, film, plastics can be made by the conventional method of this field
Type.
It is worth noting that alanyl glutamine has the biosynthesis for increasing gucosamine, amidohexose, mucoprotein
With promote the bioactivity such as chronic ulcer tissue regeneration, can also improve organism metabolism, nitrogen balance, increase total number of lymphocytes, effectively adjust
The effect for saving immune response, improving organism metabolism situation, improving antioxidant ability of organism；Sodium Gualenate has anti-inflammatory, promotion meat
Bud is formed and the effect of epithelial cell new life；Tea polyphenols have the function of sterilization, antibacterial, anti-inflammatory；Allantoin, which has, promotes cell
It grows, accelerate wound healing, preventing the effects of cicatricial tissue generates after ulcer healing, being the good consolidant of skin trauma and anti-
Ulcer medicine.Menthol has the function of fragrance analgesic, refrigerant and local anaesthesia.The combination of these ingredients for ulcer healing and
Synergistic effect is played in recurrence, has significant therapeutic effect.
Macromolecule glue material, which is utilized, in another aspect of the present invention can form that bioadhesive is good, tissue affinity is strong, thorn
Swash that property is small, the good gel of biocompatibility, bioadhesive material can make preparation be adhered to skin surface protection wound for a long time
The characteristics of face, slow release drug, macromolecule filming material can form film.
Specific embodiment
The invention is described further below with reference to embodiment, but should not be construed the above-mentioned master of the invention
Topic range is only limitted to following embodiments.Without departing from the technical idea of the present inventions, common according to this field
Technological know-how and customary means make various replacements and change, should all include in the protection scope of the invention.
Embodiment 1
Composition:
It disperses hypromellose in suitable 80 DEG C of water for injection (preferably: 1%, w/w, hydroxypropyl methylcellulose
Element/water), wait be completely dissolved, it is placed in 4 DEG C of refrigerators cooling.The hypromellose is a kind of bioadhesive polymer.This reality
It applies in example, hypromellose can be substituted for the carbomer or Sodium Hyaluronate of constant weight.
It weighs poloxamer188 (2.5g) to be dissolved in above-mentioned system, then is placed in 4 DEG C of refrigerators and refrigerates, it is sufficiently molten to it
Solution.Said ratio is finally pressed, is sequentially added: alanyl glutamine, Sodium Gualenate, tea polyphenols, allantoin and menthol, to molten
Solution completely, that is, obtains product.In the present embodiment, the poloxamer188 can also be substituted for the chitosan of constant weight, or poly-
Ethylene glycol and its ester.
The alanyl glutamine preparation prepared in this example also has temperature in addition to preferable bioadhesive
Sensitive feature is the liquid flowed freely that is, under low-temperature condition, and is changed into semi-solid gel when body temperature, and patient is using
When it is more convenient.
Embodiment 2
Composition:
It weighs chitosan 0.15g to be dissolved in water for injection, place at room temperature, after it is sufficiently swollen, by Sodium Hyaluronate
It is scattered in above-mentioned chitosan aqueous solution system, stands, so that it is uniformly dispersed, by said ratio, sequentially add: alanyl paddy ammonia
Amide, Sodium Gualenate, tea polyphenols, allantoin and menthol, it is to be dissolved complete, that is, obtain product.
The alanyl glutamine preparation of this example preparation also has and ulcer table in addition to good bioadhesive
The good biocompatibility in face, this is because when chitosan acts on canker sore surface, due to its aminoglucan molecular band
There is positive charge can be permanent with the skin surface with negative electrical charge and closely adhere to, while enabling drug ingedient therein slowly
Release is locally maintaining stable drug concentration for a long time, is playing therapeutic effect.In addition, chitosan has higher albumen
Adsorption capacity and selectively height inhibit the effect of Streptococcus oralis growth, while having no effect on the life of other beneficial bacterias
It is long.Chitosan itself can degradation in vivo be aminoglucan, and aminoglucan be human body chondroitin, hyaluronic acid it is main
Component part, nontoxic to the human body, without carcinogenic, teratogenesis, mutagenesis, while its degradation product easily absorbs, and no antigen will not
It is quick, no haemolysis, no rejection phenomenon.
Embodiment 3
It weighs poloxamer188 (2.5g) to be dissolved in cold water for injection, is placed in 4 DEG C of refrigerators and refrigerates, it is sufficiently molten to it
Xie Hou stands by carbomer dispersion in above-mentioned poloxamer188 water solution system, it is made to be uniformly dispersed, by said ratio,
It sequentially adds: alanyl glutamine, Sodium Gualenate, tea polyphenols, allantoin and menthol, it is to be dissolved complete, that is, obtain product.
The alanyl glutamine formulation strengths prepared in this example are preferable, this is because carbomer is in addition to can be enhanced
Outside preparation adhesiveness, it is also remarkably improved the mechanical strength of preparation.
Embodiment 4:
It weighs polylactide-co-glycolide-polyethyleneglycol block copolymer (PLGA-PEG-PLGA) about 2.0g and is dissolved in injection
It in water, dissolves it sufficiently under the conditions of magnetic agitation, then disperses above-mentioned Aqueous Polymer Systems for Sodium Hyaluronate
In, it stands, so that it is uniformly dispersed, by said ratio, sequentially add: alanyl glutamine, Sodium Gualenate, tea polyphenols, allantois
Element and menthol, it is to be dissolved complete, that is, obtain product.
The alanyl glutamine preparation prepared in this example has good biodegradability and longer maintenance
Time.PLGA-PEG-PLGA is one kind of the block copolymer of polyethylene glycol and its ester, which is made for chemical synthesis,
Small-molecule substance can be gradually degraded in vivo, and degradation time is longer than other gel rubber materials, the length of degradation time with polymerize
Object molecular composition is related.
Embodiment 5:
It is molten to weigh polyvinyl alcohol (polyethylene, polypropylene, cellulose that the polyvinyl alcohol can be substituted for equivalent) 0.95g
In water for injection, place at room temperature, after it is sufficiently swollen, be added hypromellose 0.25g and be heated to 80 DEG C to
After being completely dissolved, it is cooled to room temperature；It weighs chitosan 0.03g to be dissolved in above-mentioned solution, be placed after it is sufficiently swollen at room temperature,
It is uniformly mixed it, is stood；Said ratio is finally pressed, is sequentially added: alanyl glutamine, Sodium Gualenate, tea polyphenols, allantois
Element and menthol, it is to be dissolved completely after, film, after dry, demoulding, cutting, i.e. acquisition product.
The alanyl glutamine bioadhesive gel film prepared in this example has good adhesion and the surface of a wound
Protectiveness, and there is longer therapeutic effect.Polyvinyl alcohol, hypromellose are common filmogens, are had fine
Viscosity and film forming, it is nontoxic, it is nonirritant, property stablize, do not work with other drugs, do not influence drug effect, filming performance
Well and make effective component that there is slow releasing function.
Embodiment 6:
Just the pharmacodynamics animal experiment of alanyl glutamine bioadhesive preparation of the present invention is described further below.
(1) animal model
Using traumatic canker sore animal model, method for building animal model: with an internal diameter 0.6cm, the glass of long 3cm
Glass pipe is perpendicularly fixed at rabbit oral mucosa surface, and the glacial acetic acid 0.2ml that injected slurry volume score is 30% into pipe is used after 30 seconds
Cotton swab dips in out glacial acetic acid, and next day forms ulcer, ulcer diameter generally about 0.2 ~ 0.3cm.
(2) ulcer healing situation compares
After ulcer is formed, (pass through implementation using alanyl glutamine bioadhesive gel product in ulcer surface respectively
Example 1~5 obtains) be the drug of active constituent, bFGF(growth factor) and blank control group (any treatment is not taken to arrange
Apply), visually observe ulcer healing situation, use within every six hours simultaneously record it is primary, using do not observe mucosal ulcer and it is congested as
Healing standard.
1 alanyl glutamine bioadhesive gel of table, bFGF and blank control group ulcer healing situation table
Note: through K-W rank sum test, self-control gel group ulcer healing is fastest, P < 0.05
The advantages of establishing Ulcer Models using 30% glacial acetic acid inustion is to be not required to that anesthesia, dosage is accurate, is easy to control, lures
The ulcer of hair is reproducible.By 54h, the ulcer on animal oral cavity mucous membrane heals, alanyl glutamine bioadhesive
Gel group ulcer healing is most fast (P < 0.05), and in 18h, all ulcer heal.
Claims (1)
1. a kind of for treating the pharmaceutical preparation of canker sore, it is characterised in that:
Composition and ratio are as follows: 5 ~ 10 parts of alanyl glutamine, 0.02 ~ 0.05 part of Sodium Gualenate, 5 ~ 10 parts of tea polyphenols, allantoin
5 ~ 10 parts, 1 ~ 2 part of menthol, 1 ~ 25 part of Macromolecule glue material, 0.1 ~ 5 part of bioadhesive polymer；Macromolecule filming material 1 ~ 15
Part；
Its prepare the following steps are included:
1) macromolecule filming material is dissolved in water for injection, so that it is sufficiently dissolved or is swollen, is cooled to room temperature；
2) Macromolecule glue material is dissolved in 1) system, it is made sufficiently to dissolve or be swollen；
3) above-mentioned 2) gel rubber system then is dispersed by bioadhesive polymer, stands, it is made to be uniformly dispersed；
4) alanyl glutamine, Sodium Gualenate, tea polyphenols, allantoin and menthol are added in above-mentioned solvent, it is to be dissolved
Completely, that is, product is obtained.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510301385.XA CN105561289B (en) | 2013-08-27 | 2013-08-27 | It is a kind of for treating the pharmaceutical preparation of canker sore |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510301385.XA CN105561289B (en) | 2013-08-27 | 2013-08-27 | It is a kind of for treating the pharmaceutical preparation of canker sore |
| CN201310375582.7A CN103405747B (en) | 2013-08-27 | 2013-08-27 | Preparation method for alanyl-glutamine biological adhesive preparation as well as product and application of preparation |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
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| CN201310375582.7A Division CN103405747B (en) | 2013-08-27 | 2013-08-27 | Preparation method for alanyl-glutamine biological adhesive preparation as well as product and application of preparation |
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| CN105561289A CN105561289A (en) | 2016-05-11 |
| CN105561289B true CN105561289B (en) | 2019-05-07 |
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| CN201510301385.XA Active CN105561289B (en) | 2013-08-27 | 2013-08-27 | It is a kind of for treating the pharmaceutical preparation of canker sore |
| CN201510301338.5A Active CN105561288B (en) | 2013-08-27 | 2013-08-27 | A kind of bioadhesive hydrogel and film containing alanyl glutamine |
| CN201310375582.7A Active CN103405747B (en) | 2013-08-27 | 2013-08-27 | Preparation method for alanyl-glutamine biological adhesive preparation as well as product and application of preparation |
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| CN201310375582.7A Active CN103405747B (en) | 2013-08-27 | 2013-08-27 | Preparation method for alanyl-glutamine biological adhesive preparation as well as product and application of preparation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104644460A (en) * | 2015-03-06 | 2015-05-27 | 北京华素制药股份有限公司 | Medicinal toothpaste composition and preparation method and application thereof |
| CN106110293A (en) * | 2016-07-12 | 2016-11-16 | 东莞市万佳医疗科技有限公司 | Spraying agent for ulcer of oral cavity and preparation method thereof |
| CN106565902B (en) * | 2016-10-21 | 2018-05-04 | 长春工业大学 | A kind of bionical cohesive hydrogel of snail and preparation method thereof |
| CN106580941B (en) * | 2017-03-02 | 2019-02-26 | 河北医科大学生物医学工程中心 | A kind of powder and preparation method thereof of gargling containing sodium azulenesulfonate |
| CN107412200B (en) * | 2017-04-27 | 2018-07-24 | 哈尔滨乾佰纳生物药业有限公司 | A kind of slow-release stomatocace film and preparation method thereof with bioadhesive |
| CN108420889A (en) * | 2018-03-16 | 2018-08-21 | 江阴金泰克生物技术有限公司 | A kind of gel and preparation method thereof for treating canker sore |
| CN110090198B (en) * | 2019-05-09 | 2020-02-21 | 哈尔滨乾佰纳生物药业有限公司 | Slow-release type oral ulcer gel with biological adhesion and preparation method thereof |
| CN113827733A (en) * | 2020-06-16 | 2021-12-24 | 深圳长久康联生物科技有限公司 | Cold compress gel, and use method and application thereof |
| CN112426403B (en) * | 2020-12-09 | 2021-09-17 | 南京天纵易康生物科技股份有限公司 | Oral ulcer gel and preparation method and application thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1861064A (en) * | 2006-06-15 | 2006-11-15 | 西安利君制药有限责任公司 | Medicine composition contg. sodium azulene sulfonate and L-glutamine water-soluble precursor |
| CN102600122A (en) * | 2011-12-02 | 2012-07-25 | 辽宁盛生医药集团有限公司 | Paster for treating dental ulcer and preparation method thereof |
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2013
- 2013-08-27 CN CN201510301385.XA patent/CN105561289B/en active Active
- 2013-08-27 CN CN201510301338.5A patent/CN105561288B/en active Active
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1861064A (en) * | 2006-06-15 | 2006-11-15 | 西安利君制药有限责任公司 | Medicine composition contg. sodium azulene sulfonate and L-glutamine water-soluble precursor |
| CN102600122A (en) * | 2011-12-02 | 2012-07-25 | 辽宁盛生医药集团有限公司 | Paster for treating dental ulcer and preparation method thereof |
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| Title |
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| 茶多酚口腔凝胶的制备及质量控制;吴继禹等;《海峡药学》;20071231;第19卷(第4期);第14页左栏第4-9行及讨论部分4.4 |
Also Published As
| Publication number | Publication date |
|---|---|
| CN105561289A (en) | 2016-05-11 |
| CN105561288A (en) | 2016-05-11 |
| CN103405747B (en) | 2015-06-17 |
| CN105561288B (en) | 2019-05-07 |
| CN103405747A (en) | 2013-11-27 |
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