【発明の詳細な説明】本発明は歯周炎等の歯周疾患を予防、治療するための予
防治療剤に関する。DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a prophylactic and therapeutic agent for preventing and treating periodontal diseases such as periodontitis.
歯周炎等の歯周疾患の原因は、種々数えられるが、口腔
内に存在する歯垢形成性細菌に起因するところが大きい
といわれており、このため歯周疾患を予防、治療する方
法としては、従来殺菌剤を用いて歯垢形成性細菌を殺菌
する方法が知られている。しかしながら、この方法は殺
菌剤により対象とする細菌以外の細菌をも殺菌してしま
い口腔内細菌叢を著しく変化させてしまうおそれがある
上、歯周ポケット部位に対しては有効性が低い等の問題
がある。また、口腔内細菌のうち、バクテロイデス（３
ａｃｔｅｒｏ＊ｃｔｅｓ）類やアクチノマイセス（Ａ
ｃｔ ｉ ｎｏｍｙｃｅｓ ）類に対しては、その抗体
により受動免疫する方法も提案されているが、実用段階
には至っていない。There are various causes of periodontal diseases such as periodontitis, but it is said that plaque-forming bacteria that exist in the oral cavity are the main cause.Therefore, as a method for preventing and treating periodontal diseases, 2. Description of the Related Art Conventionally, methods of sterilizing plaque-forming bacteria using disinfectants are known. However, this method uses a disinfectant to kill bacteria other than the target bacteria, which may significantly change the oral flora, and it is less effective against periodontal pockets. There's a problem. In addition, among oral bacteria, Bacteroides (3
actero*ctes) and Actinomyces (A
ct inomyces), a method of passive immunization using antibodies thereof has been proposed, but this has not yet reached the practical stage.
歯周炎等の歯周疾患は、その早期には白血球の細胞浸潤
と結合組織成分の崩壊が生じ、また確立期では結合組織
の崩壊と特に形質細胞の著しい浸潤が起ることが知られ
ており、従ってこのことがら歯周疾患の予防、治療に対
しては細胞の浸潤を抑制することが有効であると考えら
れている。It is known that in the early stages of periodontal diseases such as periodontitis, leukocyte infiltration and disruption of connective tissue components occur, and in the established stage, connective tissue disruption and especially marked infiltration of plasma cells occur. Therefore, it is considered effective to suppress cell infiltration for the prevention and treatment of periodontal diseases.
本発明者らは、上記事情に鑑み、ＷｊＪ飽の浸潤を効果
的に抑制し、歯周疾患を有効に予防、治療し得る歯周疾
患予防治療剤につき鋭意研究を行なった結果、γ−グロ
ブリンの注射による投与が効果があることを知見した。In view of the above circumstances, the present inventors have conducted extensive research into periodontal disease preventive and therapeutic agents that can effectively suppress the infiltration of WJJ and effectively prevent and treat periodontal diseases. We found that administration by injection is effective.
即ち、γ−グロブリン製剤は従来より麻しん、黄痘、ぜ
んそ（、水痘、ポリオなどの予防治療剤として知られ、
筋肉注射剤として用いられているが、従来γ−グロブリ
ンが口腔内疾患に対して有効に作用し１ｑることの知見
はない。ところが、本発明者らが検討したところによれ
ば、γ−グロブリンを注射投与した場合、意外にも歯肉
Ｉ１１胞の浸潤が効果的に抑制され、γ−グロブリンの
注射投与が歯周疾患の予防、治療に有効であるとの新知
見を得、本発明をなすに至ったものである。That is, γ-globulin preparations have been known as preventive and therapeutic agents for measles, yellow pox, asthma (chickenpox, polio, etc.).
Although it is used as an intramuscular injection, there is no knowledge that γ-globulin effectively acts on oral diseases. However, according to studies conducted by the present inventors, when γ-globulin was injected, the infiltration of gingival I11 follicles was unexpectedly effectively suppressed, and γ-globulin injection was found to be effective in preventing periodontal disease. We have obtained new knowledge that this method is effective for treatment, and have come to form the present invention.
従って、本発明は非特異性γ−グロブリンを有効成分と
し、注射剤として用いられる歯周疾患予防治療剤を提供
するものである。Therefore, the present invention provides a periodontal disease preventive and therapeutic agent containing nonspecific γ-globulin as an active ingredient and used as an injection.
以下、本発明につき更に詳しく説明する。The present invention will be explained in more detail below.
本発明の歯周疾患予防治療剤は、上述したように非特異
性γ−グロブリンを有効成分とするものであるが、本発
明予防治療剤は人又は馬、牛、山羊、豚、犬、猫等の哺
乳動物に適用されるもので、人に適用する場合には人γ
−グロブリン、哺乳動物に適用する場合には適用すべき
哺乳動物と同じ動物に由来するγ−グロブリンが使用さ
れ、これらγ−グロブリンとしては公知のものが用いら
れ得る。The preventive and therapeutic agent for periodontal disease of the present invention contains non-specific γ-globulin as an active ingredient as described above, and the preventive and therapeutic agent of the present invention is suitable for humans, horses, cows, goats, pigs, dogs, and cats. This applies to mammals such as humans, and when applied to humans, humans γ
- Globulin, when applied to mammals, γ-globulin derived from the same animal as the mammal to which it is applied is used, and known γ-globulins can be used.
ここで、上記γ−グロブリンの投与量は、体重にｇ当り
１日１０〜３００四、特に２５〜１００■とすることが
好ましい。Here, the dosage of the above-mentioned γ-globulin is preferably 10 to 300, particularly 25 to 100, per gram of body weight per day.
本発明の歯周疾患予防治療剤は、注射による投与形態で
適用されるが、この場合本発明予防治療剤は予め注射剤
として調製してもよく、また適用時に注射剤として使用
し得るような粉末等の剤型に調製することもできる。こ
こで、本発明の予防治療剤には、上記γ−グロブリン以
外に、必要によりアミノ酢酸等の安定剤、チメＯサール
等の保存剤、塩化ナトリウム等の等張化剤などを配合す
ることができ、常法に従って所望の剤型とすることがで
きる。The preventive and therapeutic agent for periodontal disease of the present invention is administered in the form of an injection; in this case, the preventive and therapeutic agent of the present invention may be prepared in advance as an injection, or may be prepared in a manner that can be used as an injection at the time of application. It can also be prepared in a dosage form such as powder. Here, in addition to the above-mentioned γ-globulin, the prophylactic and therapeutic agent of the present invention may contain stabilizers such as aminoacetic acid, preservatives such as thimeosal, isotonic agents such as sodium chloride, etc., as necessary. It can be prepared into a desired dosage form according to conventional methods.
本発明の予防治療剤は、上述したように注射によって投
与するものであるが、注射部位としては歯肉がりＴまし
く、これにより効果を高めることができる。The prophylactic and therapeutic agent of the present invention is administered by injection as described above, and the injection site is preferably the gingiva, thereby increasing the effect.
本発明によれば、人又は哺乳動物に対し、特異性Ｔ−グ
ロブリンを注射投与することで歯肉細胞の浸潤を抑制し
得、歯肉炎、辺縁性歯周炎等の歯周疾患を有効に予防、
治療することができる。According to the present invention, by injecting specific T-globulin into humans or mammals, infiltration of gingival cells can be suppressed, and periodontal diseases such as gingivitis and marginal periodontitis can be effectively treated. prevention,
Can be treated.
次に実験例を示し、本発明の効果を具体的に説明づる。Next, experimental examples will be shown to specifically explain the effects of the present invention.
［実験例］ウィスター系ラット維２０匹を実験群１０匹、対照群１
０匹の２群にわける。両群とも２８日令で離乳し、屠殺
までの１２週間（１１２１２日令１＜ｅｙｅｓ ｄｉｅ
ｔ ２０００で飼育する。実験群ラツ１へには８４日令
（１２週令）と１０９０９日令Ｍ殺３日前）にラットγ
−グロブリン（ＭｉｌｅｓＬａｂＯｒａｔＯｒｉＯ３、
Ｉ ｎｃ＠とＱ ａｐｐｅｌ Ｌ ａｂｏｒ −ａｔｏ
ｒｉｅｓ 、 Ｉ ｎｃ［）を５０１１Ｋｌずつ、合計
１００■を１匹のラットの尾静脈に注入する。また、対
照群ラットには同日令に滅菌リン酸緩衝液を１１１ずつ
、合計２７７を同様に注入する。[Experiment example] 20 Wistar rats, 10 in the experimental group and 1 in the control group
Divided into 2 groups with 0 animals. Both groups were weaned at 28 days of age and kept for 12 weeks until sacrifice (11,212 days of age).
Breed at t 2000. Experimental group rats 1 were given rats γ at 84 days old (12 weeks old) and 10909 days old (3 days before sacrifice).
- Globulin (MilesLabOratOriO3,
I nc@ and Q appel labor -ato
A total of 100 μL of each of 5011 Kl of ries, I nc[) is injected into the tail vein of one rat. In addition, rats in the control group were similarly injected with 111 sterile phosphate buffer solutions (277 in total) on the same day.
γ−グロブリン又はリン酸！！衝液の注射直後及び屠殺
直前に尾静脈又は眼窩より血液を採取する。γ-globulin or phosphoric acid! ! Blood is collected from the tail vein or orbit immediately after injection of the solution and immediately before sacrifice.
血液を４℃に３０分間放置した後、遠心（２５０Ｏｒｐ
ｍ 、１０分間）し、血清を採取し、−７０℃で保存す
る。After leaving the blood at 4°C for 30 minutes, it was centrifuged (250Orp
m, 10 min), and serum is collected and stored at −70°C.
エーテルによる屠殺直後、上下顎を生理食塩水で水洗し
、１０％ホルマリンで固定し、ｐｌａｎｋ−Ｒｙｃｈｌ
ｏ脱灰液で脱灰した後、近遠心的断面標本のためのブロ
ックセクションを作製する。Immediately after sacrifice with ether, the upper and lower jaws were washed with physiological saline, fixed with 10% formalin, and plank-Rychl.
o After decalcification with decalcification solution, prepare block sections for mesiodistal cross-section specimens.
また、Ｈｅｅｌｅｙ法に従い、パラフィン包埋し、８μ
厚さの切片を作製した後、ヘマトキシリン・エオシン重
染色を行なった標本を１匹につき上顎４枚、下顎４枚ず
つ、合計８枚を選び、多型核及び単核の浸潤細胞数を各
乳頭部で測定した。更に、１−ｉｎｅ法に従い、１匹に
つぎ８枚の標本より、セメントエナメル境より歯痒側の
孔頭部結合繊に対する浸潤領域の割合を描画装置プラニ
メーターを 。Also, according to Heeley method, paraffin-embedded, 8μ
After preparing thick sections, a total of 8 specimens were stained with hematoxylin and eosin, 4 on the upper jaw and 4 on the lower jaw for each animal, and the number of polymorphic and mononuclear infiltrating cells was determined for each papilla. Measured at Furthermore, according to the 1-ine method, the ratio of the infiltrated area to the connecting fibers of the foramen head on the pruritic side of the tooth from the cement-enamel border was determined using a planimeter drawing device using eight specimens for each animal.
使用して測定した。Measured using
浸漬細胞数及び浸ｌ１１領域の測定結果をｊｌ！１表に
示す。Check the number of immersed cells and the measurement results of the immersed area 11! It is shown in Table 1.
第１表第１表の結果より、γ−グロブリン投与群（実験群）は
対照群に比べて浸潤細胞数及び８！１潤領域が低下して
おり、従ってこのことがらγ−グロブリンの投与により
歯周疾患を有効に予防、治療し得ることが知見された。Table 1 From the results in Table 1, the γ-globulin administration group (experimental group) had a decrease in the number of infiltrating cells and the 8!1 wet area compared to the control group, and this suggests that the administration of γ-globulin It was found that periodontal disease can be effectively prevented and treated.
以下、実施例を示す。Examples are shown below.
［実施例］下記処方の注射剤を調製した。[Example]An injection with the following formulation was prepared.
人γ−グロブリン １５ 重量％アミノ酢酸 ２．２５ 〃チメロール ０．０１ 〃注射用蒸溜水１００．０１ｌｐＨ６，４〜７．２上記注射剤は、人辺縁性歯周炎を予防、治療する場合、
Ｐ１〜Ｐ２レベルの患者には炎症の軽減及び歯槽骨の吸
収を予防するため、スケーリング後、体重ｋ１７当り人
γ−グロブリン５０ｍ（上記注射剤０．３３ｉ＋Ｚ）を
炎症部位の歯顛内注射する。Human γ-globulin 15% by weight Aminoacetic acid 2.25 Thimerol 0.01 Distilled water for injection 100.01l pH 6.4-7.2 The above injection is used to prevent and treat human marginal periodontitis. ,
For patients with P1 to P2 levels, in order to reduce inflammation and prevent alveolar bone resorption, after scaling, 50 m of human γ-globulin per 17 kg of body weight (0.33 i + Z of the above injection) is injected intradentally at the site of inflammation.
また、Ｐ３レベルの患者には、スケーリング優、休ｆｆ
ｘ ｋａ当り人γ−グロブリン７５ｍｇ（上記注ＤＡ斉
１０．５０猷）を同様に注射する。In addition, for patients at P3 level, scaling excellent, rest ff
75 mg of γ-globulin per person (10.50 mg of the above note) was injected in the same manner.
犬、猫の歯周炎を予防、治療する場合、炎症の進行を防
止するために、体重ｋＧ＋当り犬又は猫γ−グロブリン
２５ｍｇ（γ−グロブリンの種類が擾口３ａづる以外は
上記注射剤と同様の組成のもの０．１７ｉｊ）を炎症部
位の歯鍜内に注射する。When preventing and treating periodontitis in dogs and cats, in order to prevent the progression of inflammation, administer 25 mg of dog or cat γ-globulin per kilogram of body weight (other than the type of γ-globulin 3a, use the above injection). A similar composition (0.17 ij) is injected into the tooth cavity at the site of inflammation.
以上の結果、いずれも良好な冶緻、効果が認められた。As a result of the above, good densification and effectiveness were observed in all cases.
出願人 ラ イ オ ン 株式会社代理人 弁理士 小 島 隆 司Applicant: Laion Co., Ltd.Agent: Patent Attorney Takashi Kojima
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP3731384AJPS60184027A (en) | 1984-03-01 | 1984-03-01 | Periodontal disease prevention and treatment agent |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP3731384AJPS60184027A (en) | 1984-03-01 | 1984-03-01 | Periodontal disease prevention and treatment agent |
| Publication Number | Publication Date |
|---|---|
| JPS60184027Atrue JPS60184027A (en) | 1985-09-19 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP3731384APendingJPS60184027A (en) | 1984-03-01 | 1984-03-01 | Periodontal disease prevention and treatment agent |
| Country | Link |
|---|---|
| JP (1) | JPS60184027A (en) |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1992000718A1 (en)* | 1990-07-03 | 1992-01-23 | Vipont Pharmaceutical, Inc. | Intragingival delivery systems for treatment of periodontal disease |
| US5324520A (en)* | 1988-12-19 | 1994-06-28 | Vipont Pharmaceutical, Inc. | Intragingival delivery systems for treatment of periodontal disease |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5324520A (en)* | 1988-12-19 | 1994-06-28 | Vipont Pharmaceutical, Inc. | Intragingival delivery systems for treatment of periodontal disease |
| WO1992000718A1 (en)* | 1990-07-03 | 1992-01-23 | Vipont Pharmaceutical, Inc. | Intragingival delivery systems for treatment of periodontal disease |
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