JP5848938B2 - Method for producing oral composition - Google Patents
Method for producing oral composition Download PDFInfo
- Publication number
- JP5848938B2 JP5848938B2 JP2011220879A JP2011220879A JP5848938B2 JP 5848938 B2 JP5848938 B2 JP 5848938B2 JP 2011220879 A JP2011220879 A JP 2011220879A JP 2011220879 A JP2011220879 A JP 2011220879A JP 5848938 B2 JP5848938 B2 JP 5848938B2
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- JP
- Japan
- Prior art keywords
- oral cavity
- oral
- test
- bacteria
- composition
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Description
本発明は口腔用組成物の製造方法に関し、詳しくは、口腔における抗菌、抗口臭、清拭、洗浄などを目的として使用される口腔用組成物の製造方法に関する。 The present invention relates to a method for producing an oral composition, and in particular, to a method for producing an oral composition used for the purpose of antibacterial, anti-bad breath, wiping, washing, etc. in the oral cavity.
従来、口腔内を清浄化しておくことにより口臭を低減することの試みがなされてきた。 Conventionally, attempts have been made to reduce bad breath by cleaning the oral cavity.
また、口腔内を清浄化しておくことは、口臭のみならず、健康という側面からも重要であり、例えば、以下のような実情がある。 Moreover, it is important to clean the oral cavity not only from bad breath but also from the aspect of health. For example, there are the following situations.
すなわち、口腔内細菌の含有量の多い唾液の誤嚥は、介護医療などで問題となっているところの、誤嚥性肺炎を惹起しており、心臓病では歯周病菌の作り出す物質が血液を介して、血管壁に着き、動脈硬化を起こし、心筋梗塞や狭心症発症の危険率が高くなると言われ、糖尿病においては歯周病の悪化が起こることがあり、そのため歯周病によって起こる疾患の発症を抑制する必要がある。このように、口腔内細菌は、これらメタボリックシンドロームに関連する病態に大きく関与していることから、莫大な医療費を必要としている。また、バージャー病と呼ばれる下肢の血行循環不全を起こす疾患も口腔内細菌の関与が検証されており、この解決の一方法として口腔管理の必要性が叫ばれている。 In other words, aspiration of saliva with a high content of oral bacteria causes aspiration pneumonia, which is a problem in nursing care, etc. It is said that the risk of developing myocardial infarction and angina pectoris increases when it reaches the blood vessel wall and causes arteriosclerosis. In diabetes, the periodontal disease may worsen, and thus the disease caused by periodontal disease. It is necessary to suppress the onset. Thus, since oral bacteria are greatly involved in the pathological conditions related to these metabolic syndromes, they require enormous medical expenses. In addition, the involvement of oral bacteria in a disease causing circulatory insufficiency of the lower limbs called Buerger's disease has been verified, and the necessity of oral management as a method of solving this has been called out.
例えば、代表的な口腔内細菌である歯周病菌は、口腔常在菌として存在し、その量によって病原性を発揮する。口腔内細菌が全くなくなることはないが、病原性を発揮しない程度のコントロールが必要とされる。従って、細菌数を常に病原性を発揮しない程度にコントロールすることが重要である。 For example, periodontal disease bacteria that are typical oral bacteria exist as oral resident bacteria, and exhibit pathogenicity depending on the amount thereof. Although oral bacteria will not disappear at all, control that does not exert pathogenicity is required. Therefore, it is important to control the number of bacteria so that it does not always exhibit pathogenicity.
ここで、歯周病菌によって起こる歯周病、いわゆる歯槽膿漏に対する治療は、歯科医院においては歯周病に対する厚生労働省の治療指針があり、ブラッシング指導、プラークコントロール、スケーリング、ルートプレーニング、と言われる、いわゆる歯垢、歯石除去、歯周ポケットの治療などが行われ、症状が進めば外科的治療や薬物療法などが行われる。しかし、現在のところ決定的な治療法はないのが実情である。例えば、従来の歯磨き剤は、基本的には機械的、物理的に歯ブラシにて研磨、刷掃を行うものであって、細菌類に対しては抗菌効果ではなく、除菌、すなわち菌を取り除くことが行われているに過ぎない。日常の生活で、口腔内細菌は食事をした後や歯磨きをした後にはその菌数は減少するが、時間が経つにつれその細菌数は増加する。 Here, treatment for periodontal disease caused by periodontal disease bacteria, so-called alveolar pyorrhea, has the Ministry of Health, Labor and Welfare's treatment guidelines for periodontal disease, and is said to be brushing guidance, plaque control, scaling, root planing So-called dental plaque, calculus removal, periodontal pocket treatment, etc. are performed, and surgical treatment and drug therapy are performed as symptoms progress. However, there are currently no definitive treatments. For example, a conventional dentifrice is basically mechanically and physically polished and cleaned with a toothbrush, and is not antibacterial for bacteria, but eliminates bacteria. It's just happening. In everyday life, the number of bacteria in the oral cavity decreases after eating or brushing teeth, but the number of bacteria increases over time.
このような機械的、物理的な除菌効果のみに頼る場合、ブラッシングの方法を間違えれば、歯の歯頭部の摩耗や歯肉に傷を付けるなどの問題が起こりやすい欠点もある。しかも、細菌を殺しているのではなく洗浄効果で洗浄できる範囲のところの細菌数の減量を行っているだけで、現状では清掃しにくい歯周ポケットの中や、歯垢などの除菌効果を刷掃（歯磨き）によって十分に得ることは困難である。 When relying only on such a mechanical and physical sterilizing effect, there is a drawback that problems such as abrasion of the tooth head of the teeth and damage to the gums are likely to occur if the brushing method is mistaken. In addition, the bacteria count is reduced only within the range that can be cleaned with a cleaning effect rather than killing bacteria. It is difficult to get enough by brushing (toothpaste).
歯周病になると、現状では決定的な治療はなく、病状の進行を止めることが治療となっている。治療のどの段階でも歯周病に関与してくるのが歯周病菌である。 When it comes to periodontal disease, there is currently no definitive treatment, and the treatment is to stop the progression of the disease state. Periodontal bacteria are involved in periodontal disease at any stage of treatment.
歯周病菌は抗生剤などの使用で効果がみられるが、長期投与には副作用、耐性菌の発生など問題があるので、その使用は症状によって短期的投与がなされる程度である。抗菌剤以外に歯周病菌に直接作用する材料、製剤はない。 Periodontal disease bacteria are effective when antibiotics are used, but long-term administration has problems such as side effects and generation of resistant bacteria. There are no materials or preparations that act directly on periodontal disease bacteria other than antibacterial agents.
また、介護医療の誤嚥性肺炎の予防のために口腔内清掃が行われているが、この口腔内清掃も単に除菌を行っているに過ぎず、抗菌とは異なる。現在のところ、抗菌効果のあるものとしては、製薬会社が提供する経口投与による抗生物質や抗菌剤だけである。これらは、口腔内で直接的に細菌に作用するものと内服薬として使用されるものがあり、口腔内で歯周ポケットなどに直接填入する抗生剤もあるが、効果はあまり評価されておらず、一般的には内服剤として使用される。内服は一度体内に取り込まれることから、副作用の発現、また、使用回数使用期間が長くなると耐性菌の発現を招くことも懸念される。そのため常時抗生剤を使用するということは不可能であり、現状でも毎日使用することができる抗生剤はない。 In addition, oral cleaning is performed to prevent aspiration pneumonia in nursing care, but this oral cleaning is merely sterilization and is different from antibacterial. At present, the only antibiotics that have antibacterial effects are antibiotics and antibacterial agents by oral administration provided by pharmaceutical companies. There are those that act directly on bacteria in the oral cavity and those that are used as internal medicines, and there are antibiotics that directly fill the periodontal pocket etc. in the oral cavity, but the effect has not been evaluated much It is generally used as an internal medicine. Since the internal use is once taken into the body, there are concerns that side effects may occur and resistance bacteria may be expressed if the number of times of use is increased. Therefore, it is impossible to always use antibiotics, and there is no antibiotic that can be used every day even in the present situation.
さらに、ノロウィルス、インフルエンザウィルスに対する抗ウィルス効果や抗菌効果を示すものとしては、アルコール系、塩素系の消毒剤が主流であるが、これらアルコール系や塩素系の消毒剤は、汚染された機材、日常使用する物品の消毒や、手指を汚染から守るために短時間水で流すなどして使用されているものの、皮膚や粘膜に為害作用があるため、有効濃度の量を、直接皮膚や粘膜に接触保持、添加などして一定時間とどめて使用することは出来ないのが現状である。 In addition, alcoholic and chlorinated disinfectants are the mainstream for showing antiviral and antibacterial effects against norovirus and influenza virus, but these alcoholic and chlorinated disinfectants are contaminated equipment, Although it is used by disinfecting daily-use items and flushing with water for a short time to protect the fingers from contamination, it has a harmful effect on the skin and mucous membranes. The current situation is that it cannot be used for a certain period of time by contact or addition.
なお、過酸化水素や過炭酸ナトリウムが殺菌効果を有するものとして知られていたが（例えば、特許文献１〜５参照）、これらを併用するという知見は一切なく、過炭酸ナトリウムは、あくまでも過酸化水素の一使用形態としての使用に過ぎず、具体的には、過酸化水素が液状であることから、その取り扱いの便宜上、粉末状の過炭酸ナトリウムとして使用するという程度に過ぎなかった。 In addition, although hydrogen peroxide and sodium percarbonate were known as having a bactericidal effect (see, for example, Patent Documents 1 to 5), there is no knowledge of using them together, and sodium percarbonate is only peroxidized. The hydrogen is only used as one form of use. Specifically, since hydrogen peroxide is in a liquid state, it has only been used as powdered sodium percarbonate for the convenience of handling.
そこで、本発明が解決しようとする課題は、口腔における抗菌、抗口臭などを可能とし、かつ、人体への為害作用のない口腔用組成物の製造方法を提供することにある。 Therefore, the problem to be solved by the present invention is to provide a method for producing an oral composition that enables antibacterial and anti-bacterial odors in the oral cavity and has no harmful effect on the human body.
本願発明者は、上記目的を達成するために鋭意検討を行った。その過程において、以下の知見に達した。 The inventor of the present application has intensively studied to achieve the above object. In the process, the following knowledge was reached.
すなわち、上述のごとく、従来、過酸化水素や過炭酸ナトリウムが殺菌効果を有するものとして知られていたが、過炭酸ナトリウムは、あくまでも過酸化水素の一使用形態としての使用に過ぎず、具体的には、過酸化水素が液状であることから、その取り扱いの便宜上、粉末状の過炭酸ナトリウムとして使用するという程度に過ぎなかった。 That is, as described above, hydrogen peroxide and sodium percarbonate have been conventionally known as having a bactericidal effect, but sodium percarbonate is only used as one form of use of hydrogen peroxide. Since hydrogen peroxide is in a liquid state, it was only used as powdered sodium percarbonate for the convenience of handling.
しかし、本発明者の検討によれば、驚くべきことに、過酸化水素、分散剤、増粘剤および界面活性剤を含む水溶液と過炭酸ナトリウム水溶液とを特定の割合で混合させて得られる反応混合液が、過酸化水素水や過炭酸ナトリウム単独での効果に比して、口腔における抗菌、抗口臭、洗浄効果などが優位に発揮されること、および、その優れた効果により、低濃度であっても十分な効果が発揮されることから、この反応混合液が人体に為害作用を有しない濃度レベルで使用しうることを見出した。 However, according to the study of the present inventor, surprisingly, a reaction obtained by mixing an aqueous solution containing hydrogen peroxide, a dispersant, a thickener and a surfactant with an aqueous sodium percarbonate solution at a specific ratio. Compared to the effects of hydrogen peroxide solution or sodium percarbonate alone, the mixed solution exhibits superior antibacterial, anti-bacterial odor, and cleaning effects in the oral cavity, and due to its superior effects, the concentration is low. Even if it is, sufficient effect is exhibited, and it has been found that the reaction mixture can be used at a concentration level that does not cause harmful effects on the human body.
本発明はこれらの知見に基づき完成されるに至った。 The present invention has been completed based on these findings.
すなわち、本発明にかかる口腔用組成物の製造方法は、過酸化水素５．５〜６．０重量％、分散剤０．００５〜０．１重量％、増粘剤４．５〜６．０重量％および界面活性剤４．５〜６．０重量％を含む水溶液１００重量部に対し、過炭酸ナトリウム２５〜３５重量％を含む水溶液１９〜２０重量部を混合して、発熱反応を起こさせる工程と、前記発熱反応が停止して得られる反応混合液を、１０倍以上の希釈倍率で希釈する工程を含む。
なお、以下では、上記本発明にかかる口腔用組成物の製造方法により製造される口腔用組成物を「本発明にかかる口腔用組成物」または「本発明の口腔用組成物」ということがある。
That is, the method for producing an oral composition according to the present invention includes 5.5 to 6.0 wt% hydrogen peroxide, 0.005 to 0.1 wt% dispersant, and 4.5 to 6.0 thickener. An exothermic reaction is caused by mixing 19 to 20 parts by weight of an aqueous solution containing 25 to 35% by weight of sodium percarbonate with 100 parts by weight of an aqueous solution containing 5% by weight and 4.5 to 6.0% by weight of a surfactant. including that a step, the reaction mixture wherein the exothermic reaction is obtained by stopping the step of dilution with 10 times the dilution.
In the following, the oral composition produced by the method for producing an oral composition according to the present invention may be referred to as “the oral composition according to the present invention” or “the oral composition of the present invention”. .
上記において、本発明にかかる口腔用組成物の製造方法は、口腔用組成物を口腔内に残留可能な剤形として製造することが好ましく、例えば、泡状またはバッカル剤であることが好ましい。また、前記バッカル剤がラグビーボール様の形状を有するものであることが好ましい。 In the above, the production method of the oral composition of the present invention, it is preferable to produce the oral compositions as a residual pharmaceutical form in the mouth, for example, be Awajoma others are Bas Kkaru agent preferable. Moreover, it is preferable that the buccal agent has a rugby ball-like shape.
本発明にかかる口腔用組成物の製造方法は、口腔における抗菌、抗口臭などを可能とし、かつ、人体への為害作用がなく、具体的には、弱アルカリ性で、粘膜、皮膚に刺激性は少なく、人体に対して安全に使用できるものである。前記において、抗菌、抗口臭などの効果は、従来の歯磨き剤のような物理的、機械的な除菌効果とは異なり、化学的な作用により発揮されるものであるので、歯の歯頸部の摩耗や歯肉に傷を付けるなどの問題は解決される。 The method for producing an oral composition according to the present invention enables antibacterial and anti-bad breath in the oral cavity and has no harmful effect on the human body. Specifically, it is weakly alkaline, and is irritating to mucous membranes and skin. It is few and can be safely used for the human body. In the above, since the antibacterial and anti-bacterial effects are different from the physical and mechanical sterilization effects such as conventional dentifrices, they are exerted by chemical action. Problems such as wear and damage to the gums are resolved.
人体への為害作用のないものであることから、口腔内に残留しても人体に影響はなく、むしろ、積極的に残留させることで、口腔における抗菌、抗口臭などの効果を持続的に発揮させることができるという利点がある。 Since it has no harmful effects on the human body, even if it remains in the oral cavity, it will not affect the human body. Rather, it will remain active so that it continuously exhibits antibacterial and anti-bad breath effects in the oral cavity. There is an advantage that can be made.
製造時または使用時において口腔内に残留可能な剤形に賦形されてなることとすれば、上記の持続性を発現させることができる。例えば、歯磨き剤や口腔洗浄剤として使用する場合、従来のように、使用後に口腔の洗浄、うがいなどの処置を必要とせず、口腔内に残留させることができ、これにより、細菌数抑制効果、抗菌効果、抗口臭効果が持続するのである。 If it is formed into a dosage form that can remain in the oral cavity at the time of manufacture or use, the above-mentioned sustainability can be expressed. For example, when used as a dentifrice or oral cleanser, it does not require treatment of the oral cavity after use, such as gargle, and can remain in the oral cavity after use, thereby reducing the number of bacteria, The antibacterial and anti-bacterial effects last.
中でも、製造時または使用時において泡状であるか、または、バッカル剤であることとすれば、以下のような効果も期待される。 Among them, the following effects can be expected if they are in the form of bubbles or are buccal agents at the time of production or use.
すなわち、製造時または使用時（例えば、容器からの噴出時）において泡状であれば、口腔内の使用する目的部位に容易に到達させることが出来、口腔内に残留可能な泡状となるので、口腔内での拡散が容易となり、細菌との接触も容易となって、その結果、口腔内の細菌数抑制がより効果的に発揮される。この効果は、日常的に使用される歯磨き剤としての用途において、特に良好に発揮される。さらに、流動性が適度に得られ、操作性に優れており、使用時に流れ落ちることがないので、臥位での使用で誤嚥させることもなく、拭き取りも容易であることから、使用後にうがいの必要がなく、飲み込んでも問題はない。この効果は、誤嚥性肺炎予防目的での口腔洗浄場面での使用において、特にその操作性が良好に発揮される。したがって、従来の口腔洗浄剤や歯磨き剤では使用後にはうがいなどによる洗浄を必要とし、嚥下しない様に口腔内より排出させる必要があるが、本発明ではこのような問題が解決される。 That is, if it is foamy at the time of manufacture or use (for example, at the time of ejection from a container), it can easily reach the target site to be used in the oral cavity and becomes a foam that can remain in the oral cavity. In addition, diffusion in the oral cavity is facilitated, and contact with bacteria is facilitated. As a result, the suppression of the number of bacteria in the oral cavity is more effectively exhibited. This effect is exhibited particularly well in applications as a dentifrice used on a daily basis. In addition, fluidity is moderately obtained, excellent operability, and does not flow down during use. No need to swallow and no problem. This effect is particularly excellent in operability when used in a mouth washing scene for the purpose of preventing aspiration pneumonia. Therefore, conventional oral cleansing agents and dentifrices require cleaning with gargle after use and must be discharged from the oral cavity so as not to swallow, but the present invention solves such problems.
また、剤形がバッカル剤であれば、耳下腺よりの流出唾液が上唇小帯と頬小帯の間にあるバッカル剤と接触することで持続的に溶解して、持続的な抗菌効果を発揮できる。これにより、口腔内の状態を抗ウィルス効果、口腔内細菌数抑制効果、口臭原因物質の分解効果による抗口臭効果が発揮できる状態にすることができる。 In addition, if the dosage form is a buccal agent, the saliva efflux from the parotid gland will dissolve continuously by contact with the buccal agent between the upper lip and cheek ligaments, resulting in a sustained antibacterial effect. Can demonstrate. Thereby, the state in the oral cavity can be brought into a state in which an antiviral effect, an effect of suppressing the number of bacteria in the oral cavity, and an anti-bad breath effect due to the decomposition effect of the bad breath causing substance can be exhibited.
さらに、バッカル剤がラグビーボール様の形状を有するものであれば、口腔内への挿入、保持が容易で、使用者に与える異物感も少なく、外部からもその存在が視認され難い。 Furthermore, if the buccal agent has a rugby ball-like shape, it can be easily inserted and held in the oral cavity, has little foreign material feeling to the user, and is hardly visually recognized from the outside.
以下、本発明にかかる口腔用組成物について詳しく説明するが、本発明の範囲はこれらの説明に拘束されることはなく、以下の例示以外についても、本発明の趣旨を損なわない範囲で適宜変更実施し得る。 Hereinafter, although the composition for oral cavity concerning this invention is demonstrated in detail, the range of this invention is not restrained by these description, and changes suitably in the range which does not impair the meaning of this invention except the following illustrations. Can be implemented.
本発明にかかる口腔用組成物は、過酸化水素５．５〜６．０重量％（一般的に市販されている３５％過酸化水素水を用いる場合、約１６〜１７重量％に相当）、分散剤０．００５〜０．１重量％、増粘剤４．５〜６．０重量％および界面活性剤４．５〜６．０重量％を含む水溶液（以下、「原料液」と略記することがある）１００重量部に対し、過炭酸ナトリウム２５〜３５重量％を含む水溶液１９〜２０重量部を混合して、発熱反応を起こさせ、前記発熱反応が停止して得られる反応混合液を、１０倍以上の希釈倍率で含むものである。 The composition for oral cavity according to the present invention comprises 5.5 to 6.0% by weight of hydrogen peroxide (corresponding to about 16 to 17% by weight when using 35% hydrogen peroxide water that is generally commercially available), An aqueous solution containing 0.005-0.1 wt% dispersant, 4.5-6.0 wt% thickener and 4.5-6.0 wt% surfactant (hereinafter abbreviated as "raw material solution"). The reaction mixture obtained by mixing 19 to 20 parts by weight of an aqueous solution containing 25 to 35% by weight of sodium percarbonate with 100 parts by weight to cause an exothermic reaction and stopping the exothermic reaction is obtained. It is included at a dilution ratio of 10 times or more.
前記分散剤としては、人体に為害作用のないものであれば、特に限定されないが、例えば、有機リン酸系のキレート剤が好ましく挙げられる。市販品としては、例えば、大道製薬社製の有機リン酸系キレート剤「ホスリン」、キレスト社製の「キレスト」、日本モンサント社製の「ラウンドアップ」などが好ましく挙げられる。 The dispersant is not particularly limited as long as it does not cause harmful effects on the human body. For example, an organic phosphate chelating agent is preferably used. Preferable examples of commercially available products include organic phosphoric acid chelating agent “Phoslin” manufactured by Daido Pharmaceutical Co., Ltd., “Chirest” manufactured by Kyrest, and “Round Up” manufactured by Monsanto Japan.
前記増粘剤としては、人体に為害作用のないものであれば、特に限定されないが、例えば、ポリエチレングリコール、キサンタンガム、カラギーナンなどが挙げられる。市販品としては三洋化成社製のポリエチレングリコール「マグロゴール」などが好ましく挙げられる。 The thickener is not particularly limited as long as it has no harmful effect on the human body, and examples thereof include polyethylene glycol, xanthan gum, and carrageenan. Preferred examples of commercially available products include polyethylene glycol “magrogol” manufactured by Sanyo Kasei Co., Ltd.
前記界面活性剤としては、人体に為害作用のないものであれば、特に限定されないが、例えば、ラウリル硫酸ナトリウム、α−オレフィンスルホン酸ナトリウム、Ｎ−アシルグルタメート、２−アルキル−Ｎ−カルボキシメチル−Ｎ−ヒドロキシエチルイミダゾリニウムベタイン、Ｎ−アシルタウレート、ショ糖脂肪酸エステル、アルキロールアマイド、ポリオキシエチレン硬化ヒマシ油、ポリグリセリン脂肪酸エステル、ポリオキシエチレンポリオキシプロピレングリコール、ポリオキシエチレンソルビタンモノステアレート、ラウロイルサルコシンナトリウム、アルキルポリグルコシド、ポリオキシエチレンアルキルエーテルスルホこはく酸塩などが挙げられる。市販品としては、第一工業製薬社製の「コスメライクＬ−１５０Ａ」などが好ましく挙げられる。 The surfactant is not particularly limited as long as it has no harmful effect on the human body. For example, sodium lauryl sulfate, sodium α-olefin sulfonate, N-acyl glutamate, 2-alkyl-N-carboxymethyl- N-hydroxyethyl imidazolinium betaine, N-acyl taurate, sucrose fatty acid ester, alkylol amide, polyoxyethylene hydrogenated castor oil, polyglycerin fatty acid ester, polyoxyethylene polyoxypropylene glycol, polyoxyethylene sorbitan monostearate Examples thereof include rate, sodium lauroyl sarcosine, alkyl polyglucoside, polyoxyethylene alkyl ether sulfosuccinate and the like. Preferred examples of the commercially available product include “Cosmelike L-150A” manufactured by Daiichi Kogyo Seiyaku Co., Ltd.
原料液中、上記成分を除く残部は、通常、水（精製水のみならず、海洋深層水、ミネラルウォーター、アルカリイオン水などであっても良い。以下、同様。）であるが、本発明の効果を害しない範囲であれば、上記以外の成分を含んでいてもよい。 In the raw material liquid, the remainder excluding the above components is usually water (not only purified water but also deep sea water, mineral water, alkaline ionized water, etc. The same shall apply hereinafter). Insofar as the effect is not impaired, components other than those described above may be included.
混合は、一般的な方法を採用すればよく、通常、原料液に過炭酸ナトリウム２５〜３５重量％を含む水溶液を添加して、従来公知の撹拌手段により撹拌する。 The mixing may be carried out by a general method. Usually, an aqueous solution containing 25 to 35% by weight of sodium percarbonate is added to the raw material liquid, and the mixture is stirred by a conventionally known stirring means.
ここで、上記の発熱反応の停止は、例えば、気泡の発泡停止をもって終息と判断する。これは肉眼的な観察により確認出来る。常温での反応を基準にすると高温になればなるほど反応が早く、温度が低い時には反応は緩やかである。この様に反応速度の調整は温度設定に負うところである。発泡が終息することで、流動性のある粘稠性の液として、本剤の原材料が得られる。例えば、発熱反応であることを利用して温度変化で判断したり、反応の際に発泡することを利用して発泡の状況で判断したりすることにより確認することもできる。 Here, the stop of the exothermic reaction is determined to be the end when, for example, the foaming stops. This can be confirmed by visual observation. Based on the reaction at room temperature, the higher the temperature, the faster the reaction, and the slower the temperature, the slower the reaction. Thus, the adjustment of the reaction rate is subject to the temperature setting. When the foaming ends, the raw material of the present agent is obtained as a fluid viscous liquid. For example, it can also be confirmed by making a judgment based on a temperature change using the exothermic reaction, or making a judgment on the foaming situation using foaming during the reaction.
本発明にかかる口腔用組成物は、上記反応混合液を１０倍以上の希釈倍率で含む。この範囲であれば、人体に対する為害作用がない。抗菌、抗口臭効果などの効果を十分に発現させるためには、好ましくは希釈倍率１５倍以下である。 The composition for oral cavity concerning this invention contains the said reaction liquid mixture in the dilution rate of 10 times or more. Within this range, there is no harmful effect on the human body. In order to sufficiently exhibit effects such as antibacterial and anti-bad breath effects, the dilution ratio is preferably 15 times or less.
上記希釈は、水による希釈だけでなく、後述する賦形剤や添加物による希釈も含む。 The dilution includes not only dilution with water, but also dilution with excipients and additives described below.
ここで、上記において、例えば、反応混合液中の水分が蒸発するなどして失われた場合には、濃縮されたのと同じであるので、濃縮された分だけ余分に希釈する必要がある。この場合の希釈も、水である必要はなく、賦形剤や添加物による希釈でもよい。 Here, in the above, for example, when the water in the reaction mixture is lost due to evaporation or the like, it is the same as the concentration, so it is necessary to dilute the amount corresponding to the concentration. The dilution in this case does not need to be water, and may be diluted with an excipient or an additive.
本発明にかかる口腔用組成物は、製造時または使用時において口腔内に残留可能な剤形に賦形されてなるものであることが好ましい。口腔内に残留させることで、抗菌、抗口臭などの効果を持続的に発揮させることができるからである。 The composition for oral cavity according to the present invention is preferably formed into a dosage form that can remain in the oral cavity at the time of production or use. This is because the effects such as antibacterial and anti-bad breath can be continuously exerted by remaining in the oral cavity.
例えば、錠剤、特に、徐々に融けて口腔内に行き渡るバッカル剤やトローチ剤などが好ましく挙げられ、中でも、上顎の歯茎と頬の間などに入れて使用されるバッカル剤が好ましい。 For example, a tablet, particularly a buccal agent or a troche that gradually melts and spreads into the oral cavity is preferable, and among them, a buccal agent that is used by inserting it between the gums of the upper jaw and the cheek is preferable.
また、（製造時または）使用時において泡状であれば、練り歯磨きと同じ様に、使用部位にとどめておくことができる。使用時は液体でも、最初は液状の様に流れることがないので、***に関係なく口腔内使用が可能である。介護医療などにおける口腔清掃に操作性がよい。使用時には練り歯磨きの様に水や唾液と混ざることで口腔内に行き渡る様になり、このように、泡状であることで、口腔内で容易に拡散し、本発明の口腔用組成物の作用が、口腔内全体に行き渡り長く残留される。なお、使用時において泡状となる場合とは、例えば、製造段階では液状としておいて、使用時に、空気などの気体と混合して泡状に吐出させる場合を言う。このときの液体と気体の混合は、例えば、噴霧の際に外部から空気などの気体を取り込む機構を備えていることで、あるいは、液体中に圧縮ガスや液化ガスを含ませておくことで可能である。 Moreover, if it is foamy at the time of use (at the time of manufacture), it can remain at the site of use in the same way as toothpaste. At the time of use, even if it is liquid, it does not flow like liquid at first, so it can be used in the oral cavity regardless of body position. Operability is good for oral cleaning in nursing care. When used, it mixes with water and saliva like toothpaste, so that it spreads into the oral cavity, thus being foamy and easily diffusing in the oral cavity, the action of the oral composition of the present invention However, it spreads throughout the oral cavity and remains for a long time. In addition, the case where it becomes foamy at the time of use refers to a case where it is made liquid at the manufacturing stage and mixed with a gas such as air and discharged at the time of use. Mixing of liquid and gas at this time is possible, for example, by providing a mechanism for taking in gas such as air from the outside at the time of spraying, or by including compressed gas or liquefied gas in the liquid It is.
したがって、本発明にかかる口腔用組成物の剤形は、液状、錠剤、徐放剤など、特に限定されないのであるが、製造時または使用時において泡状であるものや、バッカル剤などが好ましい。 Therefore, the dosage form of the composition for oral cavity according to the present invention is not particularly limited, such as liquid, tablet, sustained-release agent, etc., but is preferably a foam or buccal agent at the time of production or use.
上記において、バッカル剤を得る方法としては、上述の反応混合液を乾燥させて、これを粉末状にし、デキストリン、トウモロコシデンプン、バレイショデンプン、砂糖、ショ糖、乳糖、マンニトール、ソルビトール、エリスリトール、キシリトール、タルク、カオリン、硫酸カルシウム、炭酸マグネシウム、炭酸カルシウム、軽質無水ケイ酸、システイン、結晶セルロースなどの増量剤、賦形剤と混練したのち、公知の打錠手段により打錠する方法が挙げられる。この場合、人体への為害作用を十分に低減し、かつ、良好な効果を得るという観点から、反応混合液を乾燥させて得られた粉末を全量に対して１０〜１５重量％とし、賦形剤、増量剤を全量に対して８５〜９０重量％とすることが好ましい。 In the above, as a method for obtaining a buccal agent, the above reaction mixture is dried and powdered, and dextrin, corn starch, potato starch, sugar, sucrose, lactose, mannitol, sorbitol, erythritol, xylitol, Examples thereof include a method of kneading with a bulking agent such as talc, kaolin, calcium sulfate, magnesium carbonate, calcium carbonate, light anhydrous silicic acid, cysteine, and crystalline cellulose, and an excipient, followed by tableting by a known tableting means. In this case, from the viewpoint of sufficiently reducing the harmful effects on the human body and obtaining a good effect, the powder obtained by drying the reaction mixture is made 10 to 15% by weight with respect to the total amount, and shaped It is preferable that the amount of the agent and the extender is 85 to 90% by weight based on the total amount.
また、製造時または使用時において泡状であるものは、例えば、噴霧時に空気を取り込み、かつ、その内部や噴射口にメッシュを備えた容器に充填することで噴霧時に泡状を形成し得るものや、炭酸ガス、窒素ガス、亜酸化窒素ガス、圧縮空気などの圧縮ガスを加圧剤として加え容器に充填して泡状を形成し得るものであればよい。上述の反応混合液は、界面活性剤を含んでおり、通常は、この界面活性剤によって泡状を形成し得るものである。 Moreover, what is foamy at the time of manufacture or use, for example, can form a foamy shape at the time of spraying by taking in air at the time of spraying and filling a container equipped with a mesh inside or at the injection port Alternatively, any gas may be used as long as a compressed gas such as carbon dioxide, nitrogen gas, nitrous oxide gas, or compressed air is added as a pressurizing agent to fill the container to form a foam. The reaction mixture described above contains a surfactant, and usually a foam can be formed by this surfactant.
本発明にかかる口腔用組成物には、本発明の効果を害しない範囲で、その他の添加物、例えば、香料、ハッカ油、ミント類、その他の植物の花、果物、根、葉、果皮、樹皮などより抽出されたフレーバーに甘味料としてキシリトール、エリスリトールなどと防腐剤などの添加物を配合するようにしてもよい。 In the composition for oral cavity according to the present invention, other additives such as perfumes, mint oil, mint, flowers of other plants, fruits, roots, leaves, pericarp, as long as the effects of the present invention are not impaired. You may make it mix | blend additives, such as a preservative, and a xylitol, erythritol, etc. as a sweetener with the flavor extracted from the bark etc.
従来の歯磨き剤には、虫歯の予防や歯質の強化のためにフッ化物の添加が行われることがあるが、本発明においてもフッ素の添加は可能である。 Conventional dentifrices may be added with fluoride to prevent tooth decay and strengthen the tooth structure, but fluorine can also be added in the present invention.
歯科治療において、日常的に行われる歯内治療は根管洗浄であるが、この時に使われる洗浄液は次亜塩素酸ナトリウムと過酸化水素水を使用したりするのが通常であり粘膜への為害作用などがあるため操作性に難がある。この点、本発明にかかる口腔用組成物は、口腔内への流出にも問題なく、根管内の殺菌洗浄を行うことが出来るので新たな根管洗浄剤として用いることが出来る。従来の根管洗浄剤に変わる画期的な製剤である。 In dental treatment, the endodontic treatment that is routinely performed is root canal cleaning, but the cleaning solution used at this time usually uses sodium hypochlorite and hydrogen peroxide, which is harmful to the mucous membrane. There are difficulties in operability due to the effects. In this respect, the composition for oral cavity according to the present invention can be used as a new root canal cleaning agent because it can be sterilized and cleaned in the root canal without causing any problem of outflow into the oral cavity. It is an epoch-making preparation that replaces conventional root canal cleansing agents.
本発明にかかる口腔用組成物は、後述の実施例で実証されているように、ノロウィルス、インフルエンザウィルス、ヒトヘルペスウィルスなどの各種ウィルス類、歯周病菌、歯周病や胃疾患に関与するピロリ菌などに対し、高い抗ウィルス効果、抗菌効果を発揮するとともに、硫化水素、メチルメルカプタンなどに対し、高い分解消臭性を発揮するものである。 The oral composition according to the present invention is involved in various viruses such as norovirus, influenza virus, human herpes virus, periodontal disease, periodontal disease and stomach disease, as demonstrated in the examples described later. It exhibits high antiviral and antibacterial effects against Helicobacter pylori, and exhibits high odor eliminating properties against hydrogen sulfide and methyl mercaptan.
好適な使用形態について詳述すると以下のとおりである。 It is as follows when a suitable usage form is explained in full detail.
本発明にかかる口腔用組成物を液状や泡状で用いる場合は、例えば、布ガーゼ、不織布ガーゼ、綿球やこれらに準じたものに保持させて、これを口腔内に入れて清拭を行う方法が好ましく採用される。この清拭は、頬粘膜、歯肉部、歯など、口腔内全体を清潔にしておく場合のほか、口腔内の慢性肉芽創、慢性皮膚瘻など、特定の箇所に局所的に作用させる場合にも好適に採用できる。 When the composition for oral cavity according to the present invention is used in a liquid or foam form, for example, cloth gauze, non-woven cloth gauze, cotton ball or the like is retained, and this is placed in the oral cavity for wiping. A method is preferably employed. This cleaning is not only for keeping the entire oral cavity clean, such as the buccal mucosa, gingiva, and teeth, but also for locally acting on specific areas such as chronic granulation wounds and chronic skin fistulas in the oral cavity. It can be suitably employed.
泡状で用いる場合は、さらに、歯磨き剤のような形態で使用することもできる。 When used in the form of foam, it can also be used in the form of a dentifrice.
また、本発明にかかる口腔用組成物は、バッカル剤であることが好ましい。泡状あるいは液状であれば口腔内に長時間留め置くことは不可能であるが、バッカル剤すなわち固形であれば、口腔内に長時間留め置き抗菌効果を持続させることが出来る。従来にない方法であり、製剤である。その効果についての方法と結果については後述する。 Moreover, it is preferable that the composition for oral cavity concerning this invention is a buccal agent. If it is foamy or liquid, it cannot be retained in the oral cavity for a long time, but if it is a buccal agent, ie, solid, it can be retained in the oral cavity for a long time and the antibacterial effect can be maintained. This is an unprecedented method and preparation. The method and result about the effect will be described later.
このバッカル剤は、口腔内唾液に接触すると徐々に融解を始める。例えば、以下に図１を参照して詳述する形状と量であれば、３０分程度、持続させることが出来る。 This buccal agent begins to melt gradually when it comes into contact with oral saliva. For example, the shape and amount described in detail below with reference to FIG. 1 can be sustained for about 30 minutes.
ここで、バッカル剤とは、通常、頬と歯茎の間に使用されるものであり、徐々に口腔内に融解または粘膜に吸収させる錠剤のことである。同じ様な目的で舌下錠があるが、本剤の目的は口腔内へ緩徐に持続溶解させることにある。 Here, the buccal agent is usually used between the cheek and gum, and is a tablet that gradually melts in the oral cavity or is absorbed into the mucous membrane. There is a sublingual tablet for the same purpose, but the purpose of this drug is to slowly and continuously dissolve in the oral cavity.
例えば、図１では、上唇２１、歯２２、歯茎２３、歯肉頬移行部（歯茎と頬に挟まれてできたポケット）２４、上唇小帯２５、頬小帯２６、口蓋垂２７を有する口腔２０内（下顎部は図示を省略）において、歯肉頬移行部２４にバッカル剤１０を入れるようにしているが、バッカル剤１０をこの位置に挿入することで、安定して位置が固定される。 For example, in FIG. 1, the inside of the oral cavity 20 having the upper lip 21, teeth 22, gums 23, gingival cheek transition part (pocket formed between the gums and cheeks) 24, upper lip band 25, cheek band 26, and uvula 27. (The lower jaw is not shown), the buccal agent 10 is put into the gingival cheek transition portion 24, but the position is stably fixed by inserting the buccal agent 10 into this position.
さらに、歯肉頬移行部２４にバッカル剤１０をとどめておくことにより、両側耳下腺より流出した唾液が歯肉頬移行部２４のポケットに沿って前歯部のポケットに至ることから、バッカル剤１０は唾液に曝されて、徐々に融解させることが出来るので、口腔内全体に広がり、これにより一定時間の抗菌作用を期待できる。また、飲み込むことで中咽頭・扁桃輪におよび、含嗽剤として、ここでの抗菌効果、抗ウィルス効果も期待される。 Furthermore, by keeping the buccal agent 10 in the gingival cheek transition portion 24, saliva that has flowed out from the bilateral parotid glands reaches the anterior tooth pocket along the pocket of the gingival cheek transition portion 24. Since it can be gradually melted by being exposed to saliva, it spreads throughout the oral cavity, so that antibacterial action for a certain time can be expected. In addition, antibacterial and antiviral effects here are also expected as swallowing agents, and as a mouthwash, by swallowing.
バッカル剤としての抗菌、抗ウィルス効果は、歯周病菌、口腔内ピロリ菌、ヘルペスウィルス、ノロウィルス、インフルエンザウィルスに発揮するのみならず、口臭の原因となる物質（後述）の分解消臭を行うことから、持続的に口臭効果を発揮できる。バッカル剤の性質を遺憾なく発揮でき、これまでに類を見ない画期的な発明である。 Antibacterial and antiviral effects as buccal agents are not only exerted on periodontal disease bacteria, oral pylori bacteria, herpes virus, norovirus, influenza virus, but also eliminate the odor of substances that cause bad breath (described later) Therefore, the bad breath effect can be demonstrated continuously. It is an epoch-making invention that is unprecedented and can demonstrate the properties of buccal agents without regret.
特に、図１に示すように、バッカル剤１０の形状がラグビーボール様であると、歯肉頬移行部２４の形状に良好に適合し、バッカル剤１０が歯肉頬移行部２４から容易に脱落することなく、また、使用者において過度の違和感を生じさせず、さらに、外部からバッカル剤１０の***が目立つこともない。 In particular, as shown in FIG. 1, if the shape of the buccal agent 10 is rugby ball-like, the shape of the gingival cheek transition portion 24 is well matched, and the buccal agent 10 easily falls off from the gingival cheek transition portion 24. In addition, the user does not feel excessive discomfort and the buccal agent 10 does not stand out from the outside.
なお、ラグビーボール様とは、ラグビーボールと同様あるいはこれに類似した形状のことであり、扁平形状を有しているので歯肉頬移行部２４に入り易く異物感を生じさせ難いとともに、長軸を有しているので歯肉頬移行部２４の広い範囲にわたって配置される。 The rugby ball-like shape is a shape similar to or similar to the rugby ball, and since it has a flat shape, it is easy to enter the gingival cheek transition portion 24, and it is difficult to cause a foreign body sensation, and the long axis is Since it has, it is arrange | positioned over the wide range of the gingival cheek transition part 24. FIG.
この場合のバッカル剤の重量は、特に限定するわけではないが、挿入や固定のし易さ、十分な効果の発現といった観点から、２．０〜２．５ｇ程度が好ましい。 The weight of the buccal agent in this case is not particularly limited, but is preferably about 2.0 to 2.5 g from the viewpoints of ease of insertion and fixation and expression of sufficient effects.
以下、実施例を用いて、本発明にかかる口腔用組成物について具体的に説明するが、本発明はこれら実施例に限定されるものではない。以下において、便宜上、重量％を単に％と表記し、重量部を単に部と表記する。 Hereinafter, although the composition for oral cavity concerning this invention is concretely demonstrated using an Example, this invention is not limited to these Examples. In the following, for convenience,% by weight is simply expressed as%, and parts by weight are simply expressed as parts.
〔実施例１〕
３５％濃度の過酸化水素水１７％、ホスリン（大道製薬社製の有機リン酸系キレート剤）０．０６％、マクロゴール（三洋化成工業社製の増粘剤）５％、コスメライク（ショ糖脂肪酸エステル、第一工業製薬社製の界面活性剤）５％、イオン交換水７２．９４％の混合液を原料液とした。
[Example 1]
17% of 35% hydrogen peroxide solution, 0.06% of phosphorous (Organic phosphate chelating agent manufactured by Daido Pharmaceutical), 5% of macrogol (thickening agent manufactured by Sanyo Chemical Industries), A mixed solution of 5% sugar fatty acid ester, a surfactant manufactured by Daiichi Kogyo Seiyaku Co., Ltd., and 72.94% ion-exchanged water was used as a raw material solution.
前記原料液１００重量部に対して、３０％過炭酸ナトリウム水溶液２０重量部（過炭酸ナトリウム粉末を原料液に加えても反応が遅いため、精製水に溶解させて用いた）を加え、全量を３００ｍｌとすることで、発泡しながら発熱反応が起こった。 To 100 parts by weight of the raw material solution, 20 parts by weight of a 30% sodium percarbonate aqueous solution (the reaction was slow even when sodium percarbonate powder was added to the raw material solution was used by dissolving in purified water). By setting the amount to 300 ml, an exothermic reaction occurred while foaming.
発泡が収まり反応が停止したことを確認し、得られた反応混合液を水で１５倍に希釈することにより、本発明にかかる口腔用組成物を得た。 After confirming that the foaming was stopped and the reaction was stopped, the obtained reaction mixture was diluted 15 times with water to obtain an oral composition according to the present invention.
〔比較例１〕
市販の３５％濃度の過酸化水素水を水で１０倍に希釈することにより、比較例１にかかる組成物を得た。
[Comparative Example 1]
A commercially available 35% hydrogen peroxide solution was diluted 10 times with water to obtain a composition according to Comparative Example 1.
〔比較例２〕
過炭酸ナトリウム１ｇを水で１００倍に希釈したところ、直ちに発泡することはないが、徐々に発泡し軽微な発熱反応が起こった。
発泡が収まり反応が停止したことを確認し、これを、比較例２にかかる組成物とした。
[Comparative Example 2]
When 1 g of sodium percarbonate was diluted 100 times with water, it did not immediately foam, but gradually foamed and a slight exothermic reaction occurred.
It was confirmed that the foaming stopped and the reaction stopped, and this was used as the composition according to Comparative Example 2.
上記において、１００倍の希釈としたのは、薬事法にて口腔内に用いることのできる過酸化水素濃度が０．３％以下とされており、これに相当あるいはそれ以下の過酸化水素量である必要があるためである。 In the above, the 100-fold dilution means that the concentration of hydrogen peroxide that can be used in the oral cavity by the Pharmaceutical Affairs Law is 0.3% or less. This is because it needs to be.
〔性能評価〕
上述の実施例、比較例の各組成物を検体として、以下の殺菌効果試験、ウィルス不活性化試験、脱臭効果試験を行い、その性能を評価した。
[Performance evaluation]
Using the compositions of the above-described Examples and Comparative Examples as specimens, the following bactericidal effect test, virus inactivation test, and deodorizing effect test were performed, and the performance was evaluated.
＜殺菌効果試験＞
（歯周病菌）
試験液をＳＣＤＬＰ培地で１０倍に希釈することにより、検体の影響を受けずに生菌数が測定できることを、予備試験により確認した。
<Bactericidal effect test>
(Periodontal bacteria)
It was confirmed by a preliminary test that the viable cell count could be measured without being affected by the specimen by diluting the test solution 10 times with SCDLP medium.
１）試験菌株
ジンジバリス菌（Ｐｏｒｐｈｙｒｏｍｏｎａｓ ｇｉｎｇｉｖａｌｉｓ ＪＣＭ ８５２５）を用いた。
1) Test Bacterium The bacterium used for the examination was Porphyromonas gingivalis JCM 8525.
２）菌数測定用培地および培養条件
菌数測定用培地としては５％馬脱繊維血液加Ｂｒｕｃｅｌｌａ Ａｇａｒ（ＢＢＬ製）を用い、その培養条件としては平板塗抹培養法により、３５±１℃で５〜７日間の嫌気培養とした。
2) Bacterial count medium and culture conditions 5% horse defibrinated blood-added Brucella Agar (manufactured by BBL) was used as the bacterial count measurement medium, and the culture condition was 5 at 35 ± 1 ° C. by a plate smear culture method. Anaerobic culture for -7 days.
３）試験菌液の調製
試験菌株を５％馬脱繊維血液加Ｂｒｕｃｅｌｌａ Ａｇａｒで３５±１℃、４〜７日間嫌気培養した後、生理食塩水に浮遊させ、菌数が１０8〜１０9／ｍＬとなるように調製し、これを試験菌液とした。
3) Preparation of the test bacterial solution The test strain was anaerobically cultured at 5 ± 1 ° C. for 4-7 days in 5% equine defibrinated blood Brucella Agar, then suspended in physiological saline, and the number of bacteria was 10 8 to 10 9 / It prepared so that it might become mL, and this was made into the test microbe liquid.
４）試験操作
実施例１および比較例１，２にかかる各検体１０ｍＬに、上記試験菌液０．１ｍＬを接種し、試験液とした。各試験液は、室温で保存して、１，３および５分後にＳＣＤＬＰ培地（日本製薬社製）で直ちに１０倍に希釈し、菌数測定用培地を用いて試験液中の生菌数を測定した。
4) Test operation 10 mL of each specimen according to Example 1 and Comparative Examples 1 and 2 was inoculated with 0.1 mL of the above test bacterial solution to prepare a test solution. Each test solution is stored at room temperature, and after 1, 3 and 5 minutes, it is immediately diluted 10-fold with SCDLP medium (manufactured by Nippon Pharmaceutical Co., Ltd.), and the number of viable bacteria in the test solution is determined using the medium for measuring the number of bacteria. It was measured.
なお、対照として、生理食塩水を用いて同様に試験し、開始時および５分後に生菌数を測定した。 As a control, the same test was performed using physiological saline, and the viable cell count was measured at the start and after 5 minutes.
結果を表１に示す。 The results are shown in Table 1.
上記結果から、本発明にかかる口腔用組成物は、歯周病菌に対して殺菌効果があることが分かった。この殺菌効果は、過炭酸ナトリウム溶液や過酸化水素水のいずれに対しても優位に発現されていることから、過炭酸ナトリウム溶液や過酸化水素水を併用することの相乗効果が確認できる。 From the above results, it was found that the oral composition according to the present invention has a bactericidal effect against periodontal bacteria. Since this bactericidal effect is expressed with respect to both the sodium percarbonate solution and the hydrogen peroxide solution, the synergistic effect of using the sodium percarbonate solution and the hydrogen peroxide solution together can be confirmed.
（ピロリ菌）
試験液を０．７５％チオ硫酸ナトリウム加ＳＣＤＬＰ培地で１００倍に希釈することにより、検体の影響を受けずに生菌数が測定できることを、予備試験により確認した。
(Helicobacter pylori)
It was confirmed by a preliminary test that the number of viable bacteria can be measured without being influenced by the specimen by diluting the test solution 100 times with 0.75% sodium thiosulfate-added SCDLP medium.
１）試験菌株
ピロリ菌（Ｈｅｌｉｃｏｂａｃｔｅｒ ｐｙｌｏｒｉ ＪＣＭ １２０９３）を用いた。
1) Test strain Helicobacter pylori JCM 12093 was used.
２）菌数測定用培地および培養条件
菌数測定用培地としては５％馬脱繊維血液加Ｂｌｏｏｄ Ａｇａｒ Ｂａｓｅ Ｎｏ．２（ＯＸＯＩＤ製）を用い、その培養条件としては平板塗抹培養法により、３７±１℃で７日間の微好気培養とした。
2) Bacterial count medium and culture conditions 5% equine defibrinated blood-added blood agar base no. 2 (manufactured by OXOID) was used, and the culture condition was a microaerobic culture at 37 ± 1 ° C. for 7 days by a plate smear culture method.
３）試験菌液の調製
試験菌株を５％馬脱繊維血液加Ｂｌｏｏｄ Ａｇａｒ Ｂａｓｅ Ｎｏ．２で３７±１℃、３〜４日間微好気培養した後、生理食塩水に浮遊させ、菌数が１０8〜１０9／ｍＬとなるように調製し、これを試験菌液とした。
3) Preparation of Test Bacterial Solution The test strain was treated with 5% horse defibrinated blood-added Blood Agar Base No. Then, the cells were microaerobically cultured at 37 ± 1 ° C. for 3 to 4 days at 2 and then suspended in physiological saline to prepare a bacterial count of 10 8 to 10 9 / mL.
４）試験操作
実施例１にかかる検体１０ｍＬに、上記試験菌液０．１ｍＬを接種し、試験液とした。試験液は、３６±１℃で保存して、５，１０および２０分後に０．７５％チオ硫酸ナトリウム加ＳＣＤＬＰ培地（日本製薬社製）で直ちに１００倍に希釈し、菌数測定用培地を用いて試験液中の生菌数を測定した。
4) Test operation 10 mL of the sample according to Example 1 was inoculated with 0.1 mL of the above test bacterial solution to prepare a test solution. The test solution is stored at 36 ± 1 ° C., and after 5, 10 and 20 minutes, it is immediately diluted 100-fold with 0.75% sodium thiosulfate-added SCDLP medium (manufactured by Nippon Pharmaceutical Co., Ltd.). The number of viable bacteria in the test solution was measured.
なお、対照として、精製水を用いて同様に試験し、開始時、５，１０および２０分後に生菌数を測定した。 In addition, as a control, the same test was performed using purified water, and the viable cell count was measured after 5, 10 and 20 minutes at the start.
結果を表２に示す。 The results are shown in Table 2.
上記結果から、本発明にかかる口腔用組成物は、菌自体の増殖を抑え、放置しても菌が増殖することがなく、したがって、ピロリ菌に対して抗菌効果があることが分かった。 From the above results, it was found that the composition for oral cavity according to the present invention suppresses the growth of the bacteria themselves and does not grow even if left to stand, and therefore has an antibacterial effect against H. pylori.
なお、ピロリ菌も口腔内に生息するものは、歯周病菌の進行に関与している。胃潰瘍などの胃腸粘膜疾患を引き起こすことで知られるピロリ菌（ヘリコバクター・ピロリ）は、口腔内にも存在し、歯周病の進行でピロリ菌の検出率も高くなり、ピロリ菌が炎症を増悪させることが示唆されている。また、本発明にかかる口腔用組成物の抗ピロリ菌効果は胃内における効果も期待される。 In addition, H. pylori also inhabits the oral cavity is involved in the progression of periodontal disease bacteria. Helicobacter pylori known to cause gastrointestinal mucosal diseases such as gastric ulcers is also present in the oral cavity, and the detection rate of H. pylori increases as periodontal disease progresses, and H. pylori exacerbates inflammation. It has been suggested. Moreover, the anti-H. Pylori effect of the oral composition according to the present invention is also expected to be effective in the stomach.
＜ウィルス不活性化試験＞
（ネコカリシウィルス）
細胞維持培地で作用液を１０００倍に希釈することにより、検体の影響を受けずにウィルス感染価が測定できることを、予備試験により確認した。
<Virus inactivation test>
(Feline calicivirus)
It was confirmed by a preliminary test that the virus infection titer can be measured without being affected by the specimen by diluting the working fluid 1000 times with the cell maintenance medium.
ネコカリシウィルスは、細胞培養が不可能なノロウィルスの代替ウィルスとして広く使用されている。 Feline calicivirus is widely used as an alternative virus for norovirus that cannot be cultured in cells.
１）試験ウィルス
ネコカリシウィルス（Ｆｅｌｉｎｅ Ｃａｌｉｃｉｖｉｒｕｓ Ｆ−９ ＡＴＣＣ ＶＲ−７８２）
1) Test virus Feline calicivirus F-9 ATCC VR-782
２）使用細胞
ＣＲＦＫ細胞（大日本製薬社製）
2) Cells used CRFK cells (Dainippon Pharmaceutical Co., Ltd.)
３）使用培地
（ア）細胞増殖培地
イーグルＭＥＭ培地「ニッスイ」（日水製薬社製）に牛胎仔血清を１０％加えたものを使用した。
3) Medium used (a) Cell growth medium A medium obtained by adding 10% fetal calf serum to Eagle MEM medium “Nissui” (manufactured by Nissui Pharmaceutical) was used.
（イ）細胞維持培地
イーグルＭＥＭ培地「ニッスイ」（日水製薬社製）に牛胎仔血清を２％加えたものを使用した。
(A) Cell maintenance medium A medium obtained by adding 2% of fetal calf serum to Eagle MEM medium “Nissui” (manufactured by Nissui Pharmaceutical) was used.
４）ウィルス浮遊液の調製
（ア）細胞の培養
細胞増殖培地を用い、使用細胞を組織培養用フラスコ内に単層培養した。
4) Preparation of virus suspension (a) Cell culture Using the cell growth medium, the cells used were cultured in a single layer in a tissue culture flask.
（イ）ウィルスの接種
単層培養後にフラスコ内から細胞増殖培地を除き、試験ウィルスを接種した。次に、細胞維持培地を加えて３７±１℃の炭酸ガスインキュベーター（ＣＯ2濃度５％）内で１〜５日間培養した。
(I) Inoculation of virus After the monolayer culture, the cell growth medium was removed from the flask and inoculated with the test virus. Next, cell maintenance medium was added and cultured in a carbon dioxide incubator (CO 2 concentration 5%) at 37 ± 1 ° C. for 1 to 5 days.
（ウ）ウィルス浮遊液の調製
培養後、倒立位相差顕微鏡を用いて細胞の形態を観察し、細胞に形態変化（細胞変性効果）が起こっていることを確認した。次に、培養液を遠心分離（３０００ｒ／ｍｉｎ、１０分間）し、得られた上澄み液をウィルス浮遊液とした。
(C) Preparation of virus suspension After culturing, the morphology of the cells was observed using an inverted phase contrast microscope, and it was confirmed that morphological changes (cytopathic effects) occurred in the cells. Next, the culture solution was centrifuged (3000 r / min, 10 minutes), and the resulting supernatant was used as a virus suspension.
５）試験操作
検体１ｍｌにウィルス浮遊液０．１ｍｌを添加、混合し、作用液とした。室温で作用させ、１，５，１５および３０分後に細胞維持培地を用いて１０００倍に希釈した。
なお、精製水を対照として同様に試験し、開始時および３０分後について測定を行った。
5) Test procedure 0.1 ml of the virus suspension was added to 1 ml of the sample and mixed to obtain a working solution. It was allowed to act at room temperature and was diluted 1000-fold with cell maintenance medium after 1, 5, 15 and 30 minutes.
In addition, it tested similarly about purified water as a control | contrast, and measured about 30 minutes after the start.
６）ウィルス感染価の測定
細胞増殖培地を用い、使用細胞を組織培養用マイクロプレート（９６穴）内で単層培養した後、細胞増殖培地を除き細胞維持培地を０．１ｍｌずつ加えた。次に、作用液の希釈液０．１ｍｌを４穴ずつに接種し、３７±１℃の炭酸ガスインキュベーター（ＣＯ2濃度５％）内で４〜７日間培養した。培養後、倒立位相差顕微鏡を用いて細胞の形態変化（細胞変性効果）の有無を観察し、Ｒｅｅｄ−Ｍｕｅｎｃｈ法により５０％組織培養感染量（ＴＣｌＤ50）を算出して作用液１ｍｌ当たりのウィルス感染価に換算した。
6) Measurement of virus infectivity titer Using the cell growth medium, the used cells were cultured in a monolayer in a tissue culture microplate (96 wells), and then the cell growth medium was removed and 0.1 ml of cell maintenance medium was added. Next, 0.1 ml of the working solution dilution was inoculated into every 4 wells and cultured in a 37 ± 1 ° C. carbon dioxide incubator (CO 2 concentration 5%) for 4-7 days. After culturing, the presence or absence of cell morphological change (cytopathic effect) was observed using an inverted phase contrast microscope, and the 50% tissue culture infectious dose (TCD D 50 ) was calculated by the Reed-Münch method to determine the virus per ml of working solution. Converted to infectious titer.
結果を表３に示す。 The results are shown in Table 3.
上記結果から、本発明にかかる口腔用組成物は、ネコカリシウィルスを不活性化する効果、したがって、ノロウィルスを不活性化する効果があることが分かった。 From the above results, it was found that the composition for oral cavity according to the present invention has an effect of inactivating feline calicivirus, and thus an effect of inactivating norovirus.
（インフルエンザＡ）
細胞維持培地で作用液を１００００倍に希釈することにより、検体の影響を受けずにウィルス感染価が測定できることを、予備試験により確認した。
(Influenza A)
It was confirmed by a preliminary test that the virus infection titer can be measured without being affected by the specimen by diluting the working fluid 10,000 times with the cell maintenance medium.
１）試験ウィルス
インフルエンザウィルスＡ型（Ｈ１Ｎ１)
1) Test virus Influenza virus type A (H1N1)
２）使用細胞
ＭＤＣＫ（ＮＢＬ−２）細胞 ＡＴＣＣ ＣＣＬ−３４株（大日本製薬社製）
2) Used cells MDCK (NBL-2) cells ATCC CCL-34 strain (Dainippon Pharmaceutical Co., Ltd.)
３）使用培地
（ア）細胞増殖培地
イーグルＭＥＭ培地「ニッスイ」（日水製薬社製）に牛胎仔血清を１０％加えたものを使用した。
3) Medium used (a) Cell growth medium A medium obtained by adding 10% fetal calf serum to Eagle MEM medium “Nissui” (manufactured by Nissui Pharmaceutical) was used.
（イ）細胞維持培地
以下の組成の培地を使用した。
イーグルＭＥＭ培地「ニッスイ」（日水製薬社製） １０００ｍｌ
１０％ＮａＨＣＯ3 １４ｍｌ
Ｌ−グルタミン（３０ｇ／ｌ） ９．８ｍｌ
１００×ＭＥＭ用ビタミン液 ３０ｍｌ
１０％アルブミン ２０ｍｌ
０．２５％トリプシン ２０ｍｌ
(A) Cell maintenance medium A medium having the following composition was used.
Eagle MEM medium "Nissui" (manufactured by Nissui Pharmaceutical) 1000ml
14% 10% NaHCO 3
L-glutamine (30 g / l) 9.8 ml
100 x MEM vitamin solution 30ml
20% 10% albumin
0.25% trypsin 20ml
４）ウィルス浮遊液の調製
ネコカリシウィルスにおける試験と共通であるので記載を省略する。
4) Preparation of virus suspension Since the test is common with the feline calicivirus test, the description is omitted.
５）試験操作
検体１ｍｌにウィルス浮遊液０．１ｍｌを添加、混合し、作用液とした。室温で作用させ、３０，６０および３００秒後に細胞維持培地を用いて１００００倍に希釈した。
なお、精製水を対照として同様に試験し、開始時および３００秒後について測定を行った。
5) Test procedure 0.1 ml of the virus suspension was added to 1 ml of the sample and mixed to obtain a working solution. It was allowed to act at room temperature and diluted 10,000 times with cell maintenance medium after 30, 60 and 300 seconds.
Purified water was tested in the same manner as a control, and measurement was performed at the start and after 300 seconds.
６）ウィルス感染価の測定
ネコカリシウィルスにおける試験と共通であるので記載を省略する。
6) Measurement of virus infectivity titer The description is omitted because it is common with the test for feline calicivirus.
結果を表４に示す。 The results are shown in Table 4.
上記結果から、本発明にかかる口腔用組成物は、インフルエンザＡを不活性化する効果があることが分かった。 From the above results, it was found that the composition for oral cavity according to the present invention has an effect of inactivating influenza A.
（ヒトヘルペスウィルス）
細胞維持培地で作用液を１００倍に希釈することにより、検体の影響を受けずにウィルス感染価が測定できることを、予備試験により確認した。
(Human herpes virus)
It was confirmed by a preliminary test that the virus infectivity titer can be measured without being affected by the specimen by diluting the working solution 100 times with the cell maintenance medium.
１）試験ウィルス
ヒトヘルペスウィルスＩ（Ｈｕｍａｎ ｈｅｒｐｅｓｖｉｒｕｓ Ｉ ＫＯＳ ＡＴＣＣ ＶＲ−１４９３）。
1) Test virus Human herpesvirus I (Human herpesvirus I KOS ATCC VR-1493).
２）使用細胞
ＨＥｐ−２細胞：ＨＥｐ−２ ０３−１０８（大日本製薬社製）
2) Cells used HEp-2 cells: HEp-2 03-108 (Dainippon Pharmaceutical Co., Ltd.)
３）使用培地
ネコカリシウィルスにおける試験と共通であるので記載を省略する。
3) Medium used The description is omitted because it is the same as the test for feline calicivirus.
４）ウィルス浮遊液の調製
ネコカリシウィルスにおける試験と共通であるので記載を省略する。
4) Preparation of virus suspension Since the test is common with the feline calicivirus test, the description is omitted.
５）試験操作
精製水を用いて検体希釈液（１０倍希釈液）を調製し、試験液とした。試験液１ｍｌにウィルス浮遊液０．１ｍｌを添加、混合し、作用液とした。室温で作用させ、３，５および１０分後に細胞維持培地を用いて１００倍に希釈した。
なお、精製水を対照として同様に試験し、開始時および１０分後について測定を行った。
5) Test procedure A sample diluent (10-fold diluted solution) was prepared using purified water and used as a test solution. 0.1 ml of the virus suspension was added to 1 ml of the test solution and mixed to obtain a working solution. It was allowed to act at room temperature and diluted 100-fold with cell maintenance medium after 3, 5 and 10 minutes.
Purified water was tested in the same manner as a control, and measurements were made at the start and after 10 minutes.
６）ウィルス感染価の測定
ネコカリシウィルスにおける試験と共通であるので記載を省略する。
6) Measurement of virus infectivity titer The description is omitted because it is common with the test for feline calicivirus.
結果を表５に示す。 The results are shown in Table 5.
上記結果から、本発明にかかる口腔用組成物は、ヒトヘルペスウィルスを不活性化する効果があることが分かった。 From the above results, it was found that the composition for oral cavity according to the present invention has an effect of inactivating human herpesvirus.
＜脱臭効果試験＞
（硫化水素）
実施例１にかかる組成物５ｍＬを、２５ｃｍ×４０ｃｍのにおい袋（ミヤコビニル加工所製）に入れ、ヒートシールを施した後、空気３Ｌを封入し、初期ガス濃度２０ｐｐｍとなるように硫化水素を添加した。これを室温下で静置し、経過時間ごとに袋内のガス濃度をガス検知管（ガステック社製）を用いて測定した。比較のため、実施例１にかかる組成物に代えて精製水を用いた対照（水）についても同様に測定した。また、実施例１にかかる組成物および精製水のいずれも用いなかった空試験も行った。
<Deodorization effect test>
(Hydrogen sulfide)
5 mL of the composition according to Example 1 was placed in a 25 cm × 40 cm odor bag (manufactured by Miyako Vinyl Processing), heat sealed, 3 L of air was enclosed, and hydrogen sulfide was added so that the initial gas concentration was 20 ppm. . This was left still at room temperature, and the gas concentration in the bag was measured for each elapsed time using a gas detector tube (manufactured by Gastec). For comparison, the control (water) using purified water instead of the composition according to Example 1 was also measured in the same manner. In addition, a blank test was performed in which neither the composition according to Example 1 nor purified water was used.
結果を表６に示す。 The results are shown in Table 6.
上記結果から、本発明にかかる口腔用組成物は、硫化水素に対して脱臭効果があることが分かった。 From the above results, it was found that the oral composition according to the present invention has a deodorizing effect on hydrogen sulfide.
（メチルメルカプタン）
初期ガス濃度２０ｐｐｍの硫化水素に代えて初期ガス濃度８ｐｐｍのメチルメルカプタンを用いた以外は上記硫化水素の試験と同様にして試験を行った。
(Methyl mercaptan)
The test was performed in the same manner as the hydrogen sulfide test except that methyl mercaptan having an initial gas concentration of 8 ppm was used instead of hydrogen sulfide having an initial gas concentration of 20 ppm.
結果を表７に示す。 The results are shown in Table 7.
上記結果から、本発明にかかる口腔用組成物は、メチルメルカプタンに対して脱臭効果があることが分かった。 From the above results, it was found that the composition for oral cavity according to the present invention has a deodorizing effect on methyl mercaptan.
＜刺激性試験＞
７週齢のＨａｒｔｌｅｙ系雌モルモットを日本エスエルシー社から購入し、１週間予備飼育を行って一般状態に異常のないことを確認した。試験用モルモットは、ＦＲＰ製ケージに各５匹収容し、室温２２±２℃、照明時間１２時間／日に設定した飼育室において飼育した。飼料はモルモット用固形飼料「ラボＧスタンダード」（日本農産工業社製）を給与し、飲料水は水道水を自由摂取させた。
<Irritation test>
A 7-week-old Hartley female guinea pig was purchased from Japan SLC, and pre-bred for 1 week to confirm that there was no abnormality in the general state. Five test guinea pigs were housed in cages made of FRP, and were raised in a breeding room set at a room temperature of 22 ± 2 ° C. and an illumination time of 12 hours / day. The feed was a solid feed for guinea pigs "Lab G Standard" (manufactured by Nippon Agricultural Industrial Co., Ltd.), and drinking water was freely ingested with tap water.
検体を適用する試験群および対照として注射用水を適用する対照群を設定し、各群につきそれぞれ５匹のモルモットを用いた。モルモットの口腔粘液に炎症などの異常がないことを確認した後、試験に使用した。試験群には、実施例１にかかる検体、対照群には注射用水を、胃ゾンデを用いて、それぞれ０．２５ｇずつ口腔内に適用した。適用は約２時間ごとに１日４回、４日間連続して行った。各適用前ならびに最終適用後、１および４日後に口腔粘膜を肉眼的に観察し、発赤、壊死、出血および潰瘍の形成などの刺激性の有無について検索した。 A test group to which the sample was applied and a control group to which water for injection was applied were set as controls, and 5 guinea pigs were used for each group. After confirming that there was no abnormality such as inflammation in the oral mucus of the guinea pig, it was used in the test. For the test group, the sample according to Example 1 was applied to the oral cavity, and for the control group, 0.25 g of water for injection was applied to the oral cavity using a stomach tube. Application was carried out approximately every 4 hours 4 times a day for 4 consecutive days. The oral mucosa was visually observed before each application and after 1 and 4 days after the final application, and searched for irritation such as redness, necrosis, hemorrhage and ulcer formation.
試験群および対照群ともに、各適用前ならびに最終適用後１および４日のいずれにおいてもモルモットの口腔粘膜に異常は見られなかった。 In both the test group and the control group, no abnormality was observed in the oral mucosa of guinea pigs before each application and at 1 and 4 days after the final application.
したがって、本発明にかかる口腔用組成物は、モルモットの口腔粘膜に対して刺激性を示さないものと判断された。 Therefore, it was judged that the composition for oral cavity concerning this invention does not show irritation with respect to the oral mucosa of a guinea pig.
〔実施例２〕（発泡性液剤の調製例）
実施例１の組成物を用いて、発泡性液剤を調製した。
[Example 2] (Example of preparation of foamable liquid)
A foamable liquid preparation was prepared using the composition of Example 1.
具体的には、実施例１の組成物１００ｍｌに、キシリトール５ｇ、ハッカ油１滴を添加し、これを、発泡性液剤とした。 Specifically, 5 g of xylitol and 1 drop of peppermint oil were added to 100 ml of the composition of Example 1, and this was used as a foaming liquid.
この発泡性液剤は、空気などの気体と混合して泡状に吐出させて使用することができる。 This foamable liquid agent can be used by being mixed with a gas such as air and discharged in the form of foam.
〔実施例３〕（バッカル剤の調製例）
実施例１の組成物を用いて、バッカル剤を調製した。
[Example 3] (Preparation example of buccal agent)
A buccal agent was prepared using the composition of Example 1.
具体的には、以下の配合で、原料混合物（１錠当たり重量０．２２ｇ）を得て、これを打錠機で打錠することにより、ラグビーボール用の形状を有するバッカル剤を得た。 Specifically, a raw material mixture (weight 0.22 g per tablet) was obtained with the following composition, and this was tableted with a tableting machine to obtain a buccal agent having a shape for a rugby ball.
上記において、原料混合物の配合は、実施例１に記載の希釈前の反応混合液（原料液と過炭酸ナトリウム水溶液との反応液）を乾燥させたもの０．０１６ｇ、エリスリトール０．１０７ｇ、結晶セルロース０．０３９ｇ、ショ糖脂肪酸エステル０．００１ｇ、クエン酸０．０１６ｇ、アセロラフレーバー０．０４１ｇとした。 In the above, the raw material mixture was compounded by drying 0.016 g of the reaction mixture before dilution described in Example 1 (reaction liquid of the raw material liquid and sodium percarbonate aqueous solution), 0.107 g of erythritol, crystalline cellulose 0.039 g, 0.001 g of sucrose fatty acid ester, 0.016 g of citric acid, and 0.041 g of acerola flavor.
〔性能評価〕
上述の実施例３のバッカル剤を用いて、抗歯周病効果に関する臨床試験を行い、その性能を評価した。この臨床試験は、株式会社ジージー オーラルチェックセンターに依頼して行った「歯周病原細菌検査（唾液）」である。実験法および実験結果の評価は歯科領域において、口腔細菌評価に用いられている方法で実施された。
[Performance evaluation]
Using the buccal agent of Example 3 described above, a clinical test on the anti-periodontal disease effect was performed and its performance was evaluated. This clinical trial is “Periodontal Bacteria Test (Saliva)” commissioned to GS Oral Check Center. Experimental methods and evaluation of experimental results were carried out in the dental field by the method used for oral bacteria evaluation.
具体的には、歯周病を惹起する原因菌とされる下記４種類の細菌につき、実施例３のバッカル剤の口腔内使用での結果をみた。
１）Ｐ．ｇｉｎｇｉｖａｌｉｓ：強い悪臭を放つ歯周病菌。
２）Ｔ．ｄｅｎｔｉｃｏｌａ：歯周ポケットが深くなると増殖が活発になり、歯周病が進行すると歯肉に入り、歯周病の症状を悪化させる。
３）Ｔ．ｆｏｒｓｙｔｈｅｎｓｉｓ：歯周ポケットに生息し歯周病を進行させる。
４）Ｐ．ｉｎｔｅｒｍｅｄｉａ：歯を支える骨（歯槽骨）を溶かす毒素（内毒素）をもつ。女性ホルモンと関係する。
Specifically, the results of oral administration of the buccal agent of Example 3 were observed for the following four types of bacteria that cause periodontal disease.
1) P.I. gingivalis: Periodontal disease bacteria that give off a strong odor.
2) T.M. denticola: When the periodontal pocket is deepened, the proliferation becomes active, and when the periodontal disease progresses, it enters the gingiva and worsens the symptoms of the periodontal disease.
3) T.W. forsythensis: Inhabit the periodontal pocket and advance periodontal disease.
4) P.I. intermedia: Toxin (endotoxin) that dissolves bone (alveolar bone) that supports teeth. Related to female hormones.
臨床試験条件は下記１）〜３）に示すとおりである。
１）口腔内の食前１時間程度の唾液を採取する（口腔内の口腔内細菌が一番多くなるのは食事前であることから、この時間帯で採取する）。
２）５分間ガム噛みを行わせ、この間の唾液を採取する。
３）次の５分間にバッカルタブレットを口腔上顎歯肉頬移行部のポケットに置き、流出してたまった唾液を採取する。
The clinical test conditions are as shown in the following 1) to 3).
1) Collect saliva for about 1 hour before meals in the oral cavity (collected during this period because the oral bacteria in the oral cavity are most pre-meal).
2) Let chewing gum for 5 minutes and collect saliva during this period.
3) Place the buccal tablet in the pocket of the oral and maxillary gingival cheek transition area for the next 5 minutes and collect the saliva that has flowed out.
結果は下記表８に示すとおりであった。 The results were as shown in Table 8 below.
すなわち、表８は、採取された検体中の４種類の口腔内細菌（いわゆる歯周病菌）の数を測定した実際の細菌数の計測値を示しており、「バッカル剤使用前」はガム噛み時に得られた唾液のテスト結果、「バッカル剤使用５分後」はバッカル剤を使用して５分後の口腔内唾液のテスト結果である。 In other words, Table 8 shows the actual number of bacteria measured by measuring the number of four types of oral bacteria (so-called periodontal disease bacteria) in the collected samples. The test result of saliva obtained sometimes, “5 minutes after using buccal preparation” is the test result of oral saliva after 5 minutes using buccal preparation.
いずれもガム噛みの時の細菌数とバッカル剤使用時の細菌数には減少あるいは消失がみられた。 In both cases, the number of bacteria at the time of chewing gum and the number of bacteria at the time of using buccal agents were reduced or eliminated.
以上の結果から、実施例３のバッカル剤が歯周病菌に対して抗菌効果を示すことが実証された。 From the above results, it was demonstrated that the buccal agent of Example 3 exhibited an antibacterial effect against periodontal disease bacteria.
このように、本発明のバッカル剤を使用することで、口腔内細菌、歯周病菌の明らかな減少をみたことから、実際に、本発明のバッカル剤を使用することで、歯磨きの後に歯周病菌に対する抗菌効果を持続的に持たせることができると考えられる。これは、従来の製剤にはない画期的なものであり、現在の歯周病治療に役立つと考えられ、歯周病にまつわる呼吸器疾患、循環器疾患などの予防、発症に寄与できるものと考える。 As described above, by using the buccal agent of the present invention, it was observed that oral bacteria and periodontal disease bacteria were clearly reduced, so in fact, by using the buccal agent of the present invention, It is considered that the antibacterial effect against the disease bacteria can be continuously given. This is an epoch-making thing not found in conventional preparations, and is thought to be useful for the treatment of periodontal disease at present, and can contribute to the prevention and development of respiratory and cardiovascular diseases related to periodontal disease. Think.
歯周病菌に対する抗菌効果の持続のみならず、口臭の原因となるメチルメルカプタン、硫化水素などの分解も行われ、バッカル剤使用で、持続して口腔領域の細菌、ウィルスの抑制効果と同時に、抗口臭効果が期待できる。 In addition to the sustained antibacterial effect against periodontal disease bacteria, methyl mercaptan and hydrogen sulfide, which cause bad breath, are also decomposed. A bad breath effect can be expected.
本発明にかかる口腔用組成物は、例えば、口腔清拭剤や歯磨き剤、バッカルタブレットなどとして好適に利用することができる The composition for oral cavity according to the present invention can be suitably used as, for example, an oral wiping agent, a dentifrice, a buccal tablet or the like.
１０ バッカル剤
２０ 口腔
２１ 上唇
２２ 歯
２３ 歯茎
２４ 歯肉頬移行部
２５ 上唇小帯
２６ 頬小帯
２７ 口蓋垂
10 buccal agent 20 oral cavity 21 upper lip 22 tooth 23 gum 24 gingival cheek transition part 25 upper lip band 26 cheek band 27 uvula
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