CN101584889B - External in-situ forming matrix used for treating periodontal diseases - Google Patents
External in-situ forming matrix used for treating periodontal diseases Download PDFInfo
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- CN101584889B CN101584889B CN 200910016482 CN200910016482A CN101584889B CN 101584889 B CN101584889 B CN 101584889B CN 200910016482 CN200910016482 CN 200910016482 CN 200910016482 A CN200910016482 A CN 200910016482A CN 101584889 B CN101584889 B CN 101584889B
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Abstract
The invention discloses an external in-situ forming matrix used for treating periodontal diseases, which comprises in-situ forming gelata and a forming agent, wherein the in-situ forming gelata consists of the following components by weight percentage: 0.5 to 5 percent of sodium alginate, 0.5 to 3 percent of carbomer, 10 to 25 percent of glycerine, 2 to 15 percent of triethanolamine, 0.2 percent of preservative and the balance of water; and the forming agent is water solution of calcium salt, wherein the mass concentration of calcium ions is 1 to 20 percent, and the solute is any one or any combination of calcium chloride, calcium gluconate, tricalcium citrate, calcium lactate and calcium lactate gluconate. The inverter carries out in vivo and in vitro tests of the in-situ forming matrix, and the pharmacological test and result show that the in-situ forming matrix of the invention after in-situ forming can effectively fill a periodontal pocket and effectively prevent the regeneration of pathogenic bacteria, and has positive and obvious effect on the treatment of periodontitis.
Description
Technical field
The present invention relates to a kind of external in-situ forming matrix that is used to treat periodontal disease, belong to medical technical field.
Background technology
Sodium alginate is a kind of natural polysaccharide compounds from extracting algae such as Thallus Laminariae (Thallus Eckloniae), Macrocystis pyrifera (L.) Ag.s, links the linear block copolymers that form with 3 kinds of modes (MM section, GG section and MG section) through α (1-4) glycosidic bond by guluronic acid (G section) and 2 kinds of construction units of its stereoisomer mannuronic acid (M section).Alginate can be when pH value be low (under the acid medium environment) and water or multivalent ion (like calcium ion etc.) produce gel; Utilize the agglomerative characteristic of this swelling of alginate, in commercial production, often be used as gel-type vehicle, thickening agent, stabilizing agent, film material, aqueous blocker etc.In recent years, the pharmaceutical grade sodium alginate also was widely used at home, as was used to prepare sulphur ointment, the pharmaceutical preparation of blood pressure lowering class, sulfa drugs preparation etc.Safety experiment and big quantity research show that sodium alginate is extremely safe (FDA, 1985) as food additive, and it allows intake is 0～25mgkg
-D
-1(U.S. FDA/WHO) has been recorded by American Pharmacopeia at present and has been used for pharmaceuticals industry, and is main as adhesive, disintegrating agent and slow-release material in pharmaceuticals industry.
Periodontitis is the destructive disease of the complicated inflammation of a kind of cause of disease, and plaque bacteria is the initiation factor of its generation, and the enzyme of antibacterial and generation thereof, endotoxin, metabolite etc. can cause the destruction of periodontal tissue.Conventional clinical treatment can only be removed the tack bacterial plaque, can not effectively control non-tack bacterial plaque; And behind the clinical treatment; Get into food debris and antibacterial in the periodontal pocket easily once more, if antibacterial breeding once more in periodontal pocket is unfavorable for the treatment of periodontal disease very much; Even cause and the further deterioration of periodontal disease cause a series of complication.If therefore can behind the clinical treatment of routine, periodontal pocket be filled, prevent the entering of food debris and antibacterial, will help the treatment and the recovery of periodontitis.
Summary of the invention
To above-mentioned prior art, the invention provides a kind of external in-situ forming matrix that is used to treat periodontal disease, it is used for the auxiliary treatment periodontitis, can prevent effectively that food debris and antibacterial from getting into periodontal pocket, thereby help the treatment and the recovery of periodontitis.
The present invention realizes through following technical scheme:
A kind of external in-situ forming matrix that is used to treat periodontal disease; Comprise formed in situ gel and forming agent; Wherein, the formed in situ gel is made up of following components in weight percentage: sodium alginate 0.5～5%, carbomer 0.5～3%; Glycerol 10～25%, triethanolamine 2～15%, antiseptic 0.2%, surplus are water; Forming agent is the aqueous solution of calcium salt, and wherein the mass concentration of calcium ion is 1～20%, solute be in calcium chloride, calcium gluconate, citric acid tricalcium, calcium lactate, the lactic acid calcium gluconate any or appoint several kinds combination in any.
Said antiseptic is an additive commonly used in the prior art, and the present invention does not have specific (special) requirements to its composition, repeats no more at this.
When said formed in situ gel prepares, each component is mixed, be stirred to solute and dissolve fully, form gel and get final product.When forming agent prepares, calcium salt is dissolved in distilled water gets final product.
Use: accomplish conventional clinical treatment at periodontitis, after the bacterial plaque that removing is adhered to, with antibiotic or hydrogen peroxide cleaning down periodontal pocket, then the formed in situ gel is injected in the periodontal pocket, reuse forming agent flushing formed in situ gel makes its forming and hardening on the throne.
External in-situ forming matrix of the present invention can be used for the filling of periodontal pocket in the periodontal disease, also can after adding the periodontal disease therapeutic medicine, be used for the treatment of periodontal disease.
Inventor of the present invention has carried out the interior and in vitro tests of body of in-situ forming matrix; Pharmacological evaluation and result show: in-situ forming matrix of the present invention is in position after the molding; Can effectively fill periodontal pocket, effectively prevent the regeneration of pathogenic bacterium, the treatment of periodontitis is had actively significantly effect.
The specific embodiment
The present invention is further described with experiment below in conjunction with embodiment:
Embodiment 1: the preparation of in-situ forming matrix
(1) preparation of formed in situ gel: get 2g sodium alginate, 2g carbomer, 20ml glycerol, 5ml triethanolamine, 0.2g antiseptic, add distilled water, be stirred to it and dissolve fully, be the formed in situ gel to 100ml;
(2) preparation of forming agent: get calcium gluconate 10g and be dissolved in the 100ml distilled water, get 10% calcium gluconate solution.
Embodiment 2: a kind of external in-situ forming matrix; Constitute by formed in situ gel and forming agent; Wherein, the formed in situ gel is made up of following components in weight percentage: sodium alginate 0.5%, carbomer 3%; Glycerol 10%, triethanolamine 15%, antiseptic 0.2%, surplus are water.Forming agent is the aqueous solution of calcium salt, and wherein the mass concentration of calcium ion is 10%, and solute is a calcium chloride.Method for preparing is with embodiment 1.
Embodiment 3: a kind of external in-situ forming matrix is made up of formed in situ gel and forming agent, wherein; The formed in situ gel is made up of following components in weight percentage: sodium alginate 5%; Carbomer 0.5%, glycerol 25%, triethanolamine 2%, antiseptic 0.2%, surplus is a water.Forming agent is the aqueous solution of calcium salt, and wherein the mass concentration of calcium ion is 20%, and solute is a citric acid tricalcium.Method for preparing is with embodiment 1.
Embodiment 4: a kind of external in-situ forming matrix is made up of formed in situ gel and forming agent, wherein; The formed in situ gel is made up of following components in weight percentage: sodium alginate 3%; Carbomer 1%, glycerol 15%, triethanolamine 10%, antiseptic 0.2%, surplus is a water.Forming agent is the aqueous solution of calcium salt, and wherein the mass concentration of calcium ion is 1%, and solute is a calcium lactate.Method for preparing is with embodiment 1.
Embodiment 5: a kind of external in-situ forming matrix is made up of formed in situ gel and forming agent, wherein; The formed in situ gel is made up of following components in weight percentage: sodium alginate 4%; Carbomer 2.5%, glycerol 13%, triethanolamine 8%, antiseptic 0.2%, surplus is a water.Forming agent is the aqueous solution of calcium salt, and wherein the mass concentration of calcium ion is 15%, and solute is the lactic acid calcium gluconate.Method for preparing is with embodiment 1.
Embodiment 6: a kind of external in-situ forming matrix; Constitute by formed in situ gel and forming agent; Wherein, the formed in situ gel is made up of following components in weight percentage: sodium alginate 1%, carbomer 0.8%; Glycerol 18%, triethanolamine 12%, antiseptic 0.2%, surplus are water.Forming agent is the aqueous solution of calcium salt, and wherein the mass concentration of calcium ion is 5%, and solute is calcium gluconate and citric acid tricalcium, and the restriction of no consumption ratio between two solutes is as long as calcium ion concentration meets the demands.Method for preparing is with embodiment 1.
Embodiment 7: a kind of external in-situ forming matrix; Constitute by formed in situ gel and forming agent; Wherein, the formed in situ gel is made up of following components in weight percentage: sodium alginate 1.5%, carbomer 1.8%; Glycerol 22%, triethanolamine 5%, antiseptic 0.2%, surplus are water.Forming agent is the aqueous solution of calcium salt, and wherein the mass concentration of calcium ion is 8%, and solute is calcium lactate and lactic acid calcium gluconate, does not have the restriction of consumption ratio between the two, as long as calcium ion concentration meets the demands.Method for preparing is with embodiment 1.
Experiment 1: the external bacteriostatic experiment of in-situ forming matrix
With 100mL LB solid medium high pressure steam sterilization postcooling to 45 ℃, mix down dull and stereotyped with bacterium liquid 200 μ l through the test bacterium (staphylococcus aureus S) of overnight incubation.Solidify the back and on each flat board, make a call to 4 holes with the card punch of diameter 6mm; Add the penicillin of equal volume and sterilized water respectively that (2 holes add penicillin in the hole; 2 holes add sterilized water), stop after 30 seconds, respectively sucking-off penicillin and sterilized water; Choosing wherein adds in-situ forming matrix in half hole then, and the adding forming agent makes its formed in situ.With sterilized water as negative control.Testing result behind the 12h has the positive of inhibition zone, otherwise negative.Each sample is made two flat boards, averages after measuring each antibacterial circle diameter, and the result is as shown in table 1:
Table 1 different disposal mode inhibition zone situation
Can find out that by data in the table in-situ forming matrix can prolong the retention time of penicillin at affected part, improve the antibacterial effect of penicillin.Also can prolong the retention time of periodontal disease medication if it is used in periodontal disease, improve its curative effect at periodontal pocket.
Experiment 2: bacteriostatic experiment in the in-situ forming matrix body
Select patients with periodontitis 20 people totally 120 teeth, separating tests group and matched group are used in-situ forming matrix behind the conventional supragingival scaling of test group, do not handle behind the conventional supragingival scaling of matched group.Clinical symptoms according to the patient is carried out Comprehensive Assessment with the detection index, and data are seen table 2, table 3, table 4.
The result: after two groups of 4 weeks of medication, inspection and measurement GI, depth of pocket and patient's clinical symptoms are improved situation, and the test group curative effect obviously is superior to matched group (P＜001).
Conclusion: can improve the periodontal index of correlation and clinical symptoms effectively with the in-situ forming matrix treatment behind the conventional supragingival scaling.
The comparison of each item index before the table 2 liang group treatment (x ± s)
Annotate: P＞0.05
The comparison of table 3 liang group treatment back each item index (x ± s)
Annotate: P＜0.01
The comparison of table 4 liang group treatment back each item index (x ± s)
Claims (1)
1. external in-situ forming matrix that is used to treat periodontal disease is characterized in that: comprise formed in situ gel and forming agent, be one of following combination:
1. the preparation of formed in situ gel: get 2g sodium alginate, 2g carbomer, 20ml glycerol, 5ml triethanolamine, 0.2g antiseptic, add distilled water, be stirred to it and dissolve fully, be the formed in situ gel to 100ml; The preparation of forming agent: get calcium gluconate 10g and be dissolved in the 100ml distilled water, get 10% calcium gluconate solution;
2. the formed in situ gel is made up of following components in weight percentage: sodium alginate 0.5%, and carbomer 3%, glycerol 10%, triethanolamine 15%, antiseptic 0.2%, surplus is a water; Forming agent is the aqueous solution of calcium salt, and wherein the mass concentration of calcium ion is 10%, and solute is a calcium chloride;
3. the formed in situ gel is made up of following components in weight percentage: sodium alginate 5%, and carbomer 0.5%, glycerol 25%, triethanolamine 2%, antiseptic 0.2%, surplus is a water; Forming agent is the aqueous solution of calcium salt, and wherein the mass concentration of calcium ion is 20%, and solute is a citric acid tricalcium;
4. the formed in situ gel is made up of following components in weight percentage: sodium alginate 3%, and carbomer 1%, glycerol 15%, triethanolamine 10%, antiseptic 0.2%, surplus is a water; Forming agent is the aqueous solution of calcium salt, and wherein the mass concentration of calcium ion is 1%, and solute is a calcium lactate;
5. the formed in situ gel is made up of following components in weight percentage: sodium alginate 4%, and carbomer 2.5%, glycerol 13%, triethanolamine 8%, antiseptic 0.2%, surplus is a water; Forming agent is the aqueous solution of calcium salt, and wherein the mass concentration of calcium ion is 15%, and solute is the lactic acid calcium gluconate;
6. the formed in situ gel is made up of following components in weight percentage: sodium alginate 1%, and carbomer 0.8%, glycerol 18%, triethanolamine 12%, antiseptic 0.2%, surplus is a water; Forming agent is the aqueous solution of calcium salt, and wherein the mass concentration of calcium ion is 5%, and solute is calcium gluconate and citric acid tricalcium;
7. the formed in situ gel is made up of following components in weight percentage: sodium alginate 1.5%, and carbomer 1.8%, glycerol 22%, triethanolamine 5%, antiseptic 0.2%, surplus is a water; Forming agent is the aqueous solution of calcium salt, and wherein the mass concentration of calcium ion is 8%, and solute is calcium lactate and lactic acid calcium gluconate.
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| CN101584889B true CN101584889B (en) | 2012-12-12 |
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102319202B (en) * | 2011-09-30 | 2012-12-12 | 江西三九药业有限公司 | Mometasone furoate gel and preparation method thereof |
| CN102552109A (en) * | 2012-03-15 | 2012-07-11 | 山东大学 | External in-situ forming gel for treating dentin anaphylaxy |
| US11590165B2 (en) | 2014-12-17 | 2023-02-28 | Bausch Health Companies Inc. | Formulations of calcium and phosphate for oral inflammation |
| CN104586888A (en) * | 2014-12-30 | 2015-05-06 | 中国人民解放军济南军区第四零一医院 | Pharmaceutical composition for treating periodontitis and method for preparing pharmaceutical composition for treating periodontitis |
| JP7290870B2 (en) * | 2018-01-12 | 2023-06-14 | メティメディ ファーマシューティカルズ カンパニー リミテッド | Methods of treating chronic inflammatory diseases |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1813772A (en) * | 2005-11-18 | 2006-08-09 | 山东大学 | Biomedicinal gel formulation for treating alveolysis and its preparing method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1813772A (en) * | 2005-11-18 | 2006-08-09 | 山东大学 | Biomedicinal gel formulation for treating alveolysis and its preparing method |
Non-Patent Citations (1)
| Title |
|---|
| 吴少娟.Tropicaigin藻酸盐印模材料在口腔修复中的应用.《现代医院》.2006,第6卷(第2期),第51-52页. * |
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Granted publication date: 20121212 Termination date: 20190710 |