JP2016504279A - Oral care composition containing theaflavin extract - Google Patents
Oral care composition containing theaflavin extract Download PDFInfo
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- JP2016504279A JP2016504279A JP2015541903A JP2015541903A JP2016504279A JP 2016504279 A JP2016504279 A JP 2016504279A JP 2015541903 A JP2015541903 A JP 2015541903A JP 2015541903 A JP2015541903 A JP 2015541903A JP 2016504279 A JP2016504279 A JP 2016504279A
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- Prior art keywords
- composition
- oral
- theaflavins
- tea
- breath
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- 239000000284 extract Substances 0.000 title claims description 11
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- UXRMWRBWCAGDQB-UHFFFAOYSA-N Theaflavin Natural products C1=CC(C2C(CC3=C(O)C=C(O)C=C3O2)O)=C(O)C(=O)C2=C1C(C1OC3=CC(O)=CC(O)=C3CC1O)=CC(O)=C2O UXRMWRBWCAGDQB-UHFFFAOYSA-N 0.000 title description 10
- IPMYMEWFZKHGAX-ZKSIBHASSA-N theaflavin Chemical compound C1=C2C([C@H]3OC4=CC(O)=CC(O)=C4C[C@H]3O)=CC(O)=C(O)C2=C(O)C(=O)C=C1[C@@H]1[C@H](O)CC2=C(O)C=C(O)C=C2O1 IPMYMEWFZKHGAX-ZKSIBHASSA-N 0.000 title description 9
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
【課題】人と動物の口臭およびそれに関係する口腔衛生の問題、例えば歯肉炎、虫歯、歯周病、歯の過敏症の解消、および口腔内の微生物のバランスの維持について、治療および軽減するために口腔内で使用される組成物を提供する。【解決手段】本発明では、口腔衛生に有効な量のテアフラビン類、有効量の緩衝剤、約40乃至99質量%の1種または2種以上の薬学的に許容できる水溶性担体を含む組成物であって、その組成物の全水分含量が約5乃至20%である。紅茶から抽出することにより本発明の組成物を製造する方法および本発明の組成物の使用方法も開示する。【選択図】なしTo treat and alleviate bad breath of humans and animals and related oral hygiene problems such as gingivitis, caries, periodontal disease, elimination of dental sensitivity, and maintaining the balance of microorganisms in the oral cavity A composition for use in the oral cavity is provided. In the present invention, a composition comprising an effective amount of theaflavins for oral hygiene, an effective amount of a buffer, and about 40 to 99% by weight of one or more pharmaceutically acceptable water-soluble carriers. And the total water content of the composition is about 5-20%. Also disclosed are methods of producing the compositions of the present invention by extraction from black tea and methods of using the compositions of the present invention. [Selection figure] None
Description
本発明は、抗細菌性および抗菌性の保護機能を口腔内に付与するために有効なポリフェノール類を含むオーラルケア組成物に関する。さらに、本発明の組成物の口腔洗浄液としての使用により、息をさわやかにし、口臭を防止し、虫歯(う食)歯肉炎や歯周病のような歯科材料によって起きる障害を防止することができる。特に本発明の組成物は、紅茶の抽出物と緑茶の抽出物からのカテキン類とテアフラビン類とを有効量で含む。 The present invention relates to an oral care composition containing polyphenols effective for imparting antibacterial and antibacterial protective functions to the oral cavity. Furthermore, the use of the composition of the present invention as a mouthwash can refresh breath, prevent bad breath, and prevent damage caused by dental materials such as caries (caries) gingivitis and periodontal disease. . In particular, the composition of the present invention comprises catechins and theaflavins from black tea extract and green tea extract in effective amounts.
中国衛生部が2009年9月7日に公表した中国住民の口腔内衛生指南によると、国家口腔内衛生調査の結果は、う蝕(一般に虫歯として知られる)と歯周病(歯肉炎および歯周炎を含む)との最も一般的な二種類の疾患が住民の口腔内衛生を脅かしており、それらの治療は非常に困難であり、極めて多くの時間と金銭を必要とすることを報告している。 According to Chinese oral hygiene guidelines published by the Chinese Ministry of Health on September 7, 2009, the results of the National Oral Hygiene Survey show that caries (commonly known as caries) and periodontal disease (gingivitis and tooth Reported that two of the most common diseases (including peritonitis) threaten the oral hygiene of the population and are very difficult to treat and require a great deal of time and money ing.
虫歯は、組織の硬化、変色、変形、組織の変化のような諸問題を示し、ある種の口内細菌による糖発酵に伴う酸が原因となる。虫歯の初期段階は、一般に痛みや不快感を伴わない。虫歯は通常、歯科検診において歯表面の黒点や白班として発見される。さらに虫歯が進むと、う蝕が形成され、酸味のある食物又は甘い食物との接触を感知して痛みが生じ、さらに冷、熱その他の刺激に痛みを感じるようになり、ついには深刻な不快状態になる。治療せずに放置すると、歯のう蝕がさらに進み、歯が失われ、深刻な咀嚼困難になり、各人の全身の健康にまで悪影響が及ぶようになる。 Caries present problems such as tissue hardening, discoloration, deformation, tissue change, and are caused by the acid associated with sugar fermentation by certain oral bacteria. The early stages of caries are generally not painful or uncomfortable. Caries are usually found on dental surfaces as black spots or white spots on the tooth surface. As the caries progresses further, caries are formed and pain is detected upon contact with sour or sweet foods, and pain is further felt by cold, heat and other stimuli. It becomes a state. If left untreated, dental caries further progresses, teeth are lost, serious chewing becomes difficult, and the overall health of each person is adversely affected.
歯周病は、様々な疾患を有する歯の支持器官(セメント質、歯槽骨、歯肉、歯周靱帯)の周囲で起きる。その初期には、赤く腫れて触ると出血しやすい歯肉が認められる。治療せずに放置すると、歯肉の後退、歯槽骨の吸収、歯周ポケットの形成、緩んだ歯の傾き及び/又はぐらつきが生じ、歯周からの膿の漏出や口臭を伴う場合があり、最終的には歯が失われることがある。歯周病は、成人が歯を失う主な原因である。息の悪臭は、口臭と言われ、命を脅かすことはないが、恥ずかしく、きまりが悪いものである。公の場所で接する口臭は、他人にとって受け入れがたいものであり、家族も容認できない場合がある。全身性の疾患もしくは感染症となると口臭が起きる可能性もあるが、多くの場合の口臭は口腔内に原因があり、具体的には歯の表面および舌の裏側に付着している蛋白質、ペプチドまたはアミノ酸の代謝とグラム陰性嫌気性細菌の存在である。その結果、揮発性硫黄化合物(VSC)により不快な臭気が生じる。 Periodontal disease occurs around dental support organs (cementum, alveolar bone, gingiva, periodontal ligament) with various diseases. Initially, there are gingiva that are red and swollen and tend to bleed when touched. If left untreated, gingival retraction, alveolar bone resorption, formation of periodontal pockets, loose tooth inclination and / or wobble may occur, with pus leakage from the periodontium and bad breath. In some cases, teeth may be lost. Periodontal disease is a major cause of adult loss of teeth. The bad smell of breath is said to be bad breath and does not threaten life, but it is embarrassing and inconvenient. Bad breath in public places is unacceptable to others and may not be acceptable to families. Although halitosis may occur when systemic diseases or infections occur, in many cases, bad breath is caused by the oral cavity, specifically proteins and peptides attached to the tooth surface and the back of the tongue Or the metabolism of amino acids and the presence of gram-negative anaerobic bacteria. As a result, an unpleasant odor is generated by the volatile sulfur compound (VSC).
蛋白質の分解により生じる二種類の含硫アミノ酸、すなわちシステインとメチオニンは、硫化水素(H2S)およびメチルメルカプタン(CH3SH)、並びにジメチルスルフィド(Me2S)、ジメチルジスルフィド((CH3)2S2)、チオール(−SH)含有化合物を生成させ、低濃度においても強い悪臭を放つ主要な原因の一つとして機能する可能性がある。代謝過程において、少なくとも数十種類の微生物が、口の中で硫化水素、メチルメルカプタン、脂肪酸を産出する。このような細菌は、フソバクテリウム・ヘモフィルス、ウェイ・ロン球菌類(ベイロネラ)、および歯石を生じるスピロヘータであるトレポーマ・デンティコラを含む。舌の表面積を著しく増加させている舌乳頭の特殊な構造のため、舌の表面における上皮細胞の破片の離脱、食べかす、死んだ白血球細胞や細菌、歯肉下の歯垢および隣接する歯の歯垢、表面の粗さが、嫌気性細菌が生存し増殖するために理想的な環境を提供している。さらに、口臭に関係する多数の有機酸と化合物、例えば、酪酸、プロピオン酸、メチルインドール(スカトール)、カダベリン、およびインドールが存在する。 Two kinds of sulfur-containing amino acids generated by protein degradation, namely cysteine and methionine, are hydrogen sulfide (H 2 S) and methyl mercaptan (CH 3 SH), dimethyl sulfide (Me 2 S), and dimethyl disulfide ((CH 3 )). 2 S 2 ), a thiol (—SH) -containing compound, which may function as one of the main causes of strong odor even at low concentrations. During the metabolic process, at least dozens of microorganisms produce hydrogen sulfide, methyl mercaptan, and fatty acids in the mouth. Such bacteria include Fusobacterium haemophilus, Wei ronococci (Veyronella), and Trepoma denticola, a spirochete that produces tartar. Due to the special structure of the lingual papillae, which significantly increases the surface area of the tongue, the removal of epithelial cell debris on the surface of the tongue, eating away, dead white blood cells and bacteria, subgingival plaque and adjacent dental plaque The surface roughness provides an ideal environment for anaerobic bacteria to survive and grow. In addition, there are a number of organic acids and compounds related to bad breath, such as butyric acid, propionic acid, methylindole (skatole), cadaverine, and indole.
歯周病の臨床患者は、口臭の問題も抱えている場合が多い。ソダー(Soder)および他の研究者は、口臭の指標となる患者の歯垢、歯石指数、歯肉の指数および探針深さが、口臭の問題がない人々よりも高い値になることを発見した。ヤエガキおよびサナダは、食事その他の口の使用を禁止したのち、呼気中の揮発性硫黄化合物の濃度を測定している。彼らは、硫化水素およびメチルメルカプタンの濃度が、歯周の健康状態と有意に高く相関することを見いだしている。特に、メチルメルカプタンと硫化水素の濃度は、それぞれ、44.0ng/10mlと2.6ng/10mlであった。さらに、彼らは、歯周ポケットおよび出血との高い相関関係も見いだしている。同じ研究によると、健康な歯周では揮発性硫黄化合物の濃度が約50%少なくなることが判明した。別の研究では、呼気中の揮発性硫黄化合物の濃度と関係なく、探針によるポケットの深さと出血指数が、歯周病、口臭、および舌と歯肉の炎症と高い相関性を示した。これらの口腔疾患は、第一に歯垢と悪臭を放つ物質を産出する細菌の存在によって引き起こされる。従って、歯垢の除去は、個人だけではなく、オーラルヘルスケアの専門家においても、口腔内の健康を維持するために基本的に重要な点である。歯ブラシの使用、口内洗浄、歯と舌の掃除は、口内細菌の数を減少させ、口腔内の揮発性硫黄のレベルを有効に減少させ、それにより口臭が軽減する。歯ブラシを使用して、歯垢、くず、食べかすを除去することにより、良好な口腔内の健康を維持しながら、歯と歯周組織の健康状態を守ることができる。しかしながら、歯ブラシにより歯垢を除去しても、数時間で歯垢は再び歯の表面に堆積する。夜の睡眠中、唾液の分泌が減少し、歯の自己洗浄機能が低下する。そのため、夜の就寝前に歯を磨くことは重要である。 Clinical patients with periodontal disease often have bad breath problems. Soder and other researchers have found that patient plaque, calculus index, gingival index and probe depth, which are indicators of bad breath, are higher than those without bad breath problems . Yaegaki and Sanada measure the concentration of volatile sulfur compounds in exhaled breath after banning the use of food and other mouths. They find that hydrogen sulfide and methyl mercaptan concentrations correlate significantly higher with periodontal health. In particular, the concentrations of methyl mercaptan and hydrogen sulfide were 44.0 ng / 10 ml and 2.6 ng / 10 ml, respectively. In addition, they have found a high correlation with periodontal pockets and bleeding. According to the same study, it was found that the concentration of volatile sulfur compounds was reduced by about 50% in healthy periodontals. In another study, regardless of the concentration of volatile sulfur compounds in the breath, the depth of the probe pocket and the bleeding index were highly correlated with periodontal disease, halitosis, and inflammation of the tongue and gums. These oral diseases are primarily caused by the presence of bacteria that produce plaque and a foul-smelling substance. Therefore, the removal of plaque is fundamentally important for maintaining oral health not only in individuals but also in oral health care professionals. Use of a toothbrush, mouthwash, tooth and tongue cleaning reduces the number of bacteria in the mouth and effectively reduces the level of volatile sulfur in the mouth, thereby reducing bad breath. By using a toothbrush to remove plaque, litter, and food residue, the health of teeth and periodontal tissue can be protected while maintaining good oral health. However, even if the plaque is removed with a toothbrush, the plaque again accumulates on the tooth surface in a few hours. During night sleep, saliva secretion decreases and the self-cleaning function of the teeth decreases. Therefore, it is important to brush your teeth before going to bed at night.
水で口をすすぐことで口の中の食べかすを除くことができるが、それだけでは歯垢を除去するために充分でないことは明らかである。市販の口腔洗浄液は抗細菌性および抗炎症性の物質を供給するため、歯垢の抑制に有効であって、それにより口腔内の健康状態を維持することができる。例えば、フッ化物による口腔洗浄は代表的なフッ化物虫歯予防法であり、フッ化物の存在量が低い部分への適用に有効である。クロルヘキシジンによる口腔洗浄は、唾液中に存在し歯の表面に吸着している細菌を殺菌することができ、歯周病の患者に適している。エッセンシャルオイルを主要な活性成分として用いる口腔洗浄は、多くの菌に対して殺菌作用を持つことから、日常的な使用に適している。口腔洗浄には、口内炎や口唇炎からの回復やうがいに役立つものや、感染の防止や傷の治癒の促進に役立つものもある。 It is clear that rinsing with water can remove food residue in the mouth, but that alone is not sufficient to remove plaque. Since a commercially available mouth washing liquid supplies antibacterial and anti-inflammatory substances, it is effective in suppressing dental plaque, thereby maintaining the health condition in the mouth. For example, oral cleaning with fluoride is a typical method for preventing dental caries and is effective for application to portions where the amount of fluoride is low. Oral cleaning with chlorhexidine can sterilize bacteria present in saliva and adsorbed on the tooth surface, and is suitable for patients with periodontal disease. Oral cleaning using essential oil as the main active ingredient is suitable for daily use because it has a bactericidal action against many bacteria. Some mouthwashes are useful for recovering and gargle from stomatitis and cheilitis, and others are useful for preventing infection and promoting wound healing.
シュガーレスガムを噛むことも、唾液の分泌を刺激し、口腔内の酸性度を緩和し、息をさわやかにして、歯を清掃するために役に立つ。しかし、口腔用練り歯磨き、口腔洗浄溶液、その他の製品は、抗生物質(トリクロサン、フッ化第一スズ、クロルヘキシジン、四級アンモニウム塩、例、クロロフェノール)のような化学物質を含む。これらの物質は、臭気を発生する細菌を殺すことができるが、その効果は短時間で、改善効果は長時間持続しない。また、これらの物質には、味覚の変化のような望ましくない副作用をもたらすこともある。 Chewing sugarless gum also helps to stimulate saliva secretion, relieve acidity in the oral cavity, refresh your breath and clean your teeth. However, oral toothpastes, oral cleansing solutions, and other products contain chemicals such as antibiotics (triclosan, stannous fluoride, chlorhexidine, quaternary ammonium salts, eg, chlorophenol). These substances can kill odor-producing bacteria, but the effect is short and the improvement effect does not last for a long time. These substances can also have undesirable side effects such as taste changes.
茶の栽培と消費については、長い歴史がある。茶は、ポリフェノール類、テアフラビン類、テアニン、カフェインのような様々な活性成分を含む。これらの活性成分の研究と利用は、主に食物、飲料、医薬品、健康食品、および栄養補助食品の分野に限られていた。茶に含まれるカテキン系ポリフェノール類は、嫌気性細菌の増殖を抑制することができ、それにより臭気の発生も抑制できる。ハヤカワ外の特許文献1は、口腔内ケアの分野で茶を適用して、少なくとも一種の茶のポリフェノール、フッ化物およびアルミニウム塩を含む組成物により歯の酸抵抗性を高めることができることを記載している。プロクター・アンド・ギャンブル社(中国法人)による特許文献2(2002年10月9日国際公開、2010)には、有効量のポリフェノール類、緩衝剤、約40%乃至99%の一種もしくは二種以上の水溶性担体、および約5%乃至20%の全水分含量からなるオーラルケア組成物の主成分として、茶のポリフェノール類が使用できることが記載されている。 Tea cultivation and consumption has a long history. Tea contains various active ingredients such as polyphenols, theaflavins, theanine, caffeine. The research and use of these active ingredients has been mainly limited to the fields of food, beverages, pharmaceuticals, health foods and dietary supplements. Catechin-based polyphenols contained in tea can suppress the growth of anaerobic bacteria, thereby suppressing the generation of odor. Hayakawa et al., US Pat. No. 6,057,059, describes that the application of tea in the field of oral care can increase dental acid resistance with a composition comprising at least one tea polyphenol, fluoride and aluminum salt. ing. Patent Document 2 (October 9, 2002, 2010) by Procter & Gamble Co. (Chinese corporation) discloses an effective amount of polyphenols, buffering agents, about 40% to 99%, one or more. It is described that tea polyphenols can be used as the main component of an oral care composition comprising a water-soluble carrier and a total water content of about 5% to 20%.
しかしながら、紅茶の抽出物からのテアフラビン類を口内衛生に使用することについては、ほとんど報告されていない。研究を行った結果、緑茶のカテキン類が、嫌気性細菌の増殖を抑制し、硫化物の生成を低減させ、それにより悪臭、歯垢の形成、虫歯、および歯肉炎や歯周炎を含む歯周病の発生を遅延させることが判明している。しかし、緑茶のカテキン類とは異なり、紅茶中のテアフラビン類は、最も重要な活性物質である。これらは、芳香族類である天然色素の酸化または発酵により形成される重要なポリフェノール系カテキン類(カテキン(C)、エピガロカテキン(GC)、エピカテキン(EC)、3’−没食子酸エピカテキン(ECG)、エピガロカテキン・ガロカテキン(EGC)およびエピガロカテキンガラート(EGCG)など)のいくつかの二量体化により形成される。それらは、ベンゾトロポロン分子構造骨格を含むさらに複雑な茶のポリフェノール類の色素物質である。茶の発酵過程では、テアフラビン類(theaflavins, TF)およびテアルビジン類(thearubigins, テアルビン類、TR)が、茶のカテキン類(catechins)の酸化により形成される。伝統的に、この酸化過程は、発酵と呼ばれている。テアフラビン類、テアルビジン類は、茶に特有の色と香りを与える。これらのテアフラビン類は、主にテアフラビン(theaflavin, TF1)、テアフラビン−3−ガラート(theaflavin-3-gallate, TF2a)、テアフラビン−3’−ガラート(theaflavin-3'-gallate, TF2b)、およびテアフラビン−3,3’−ジガラート(theaflavin-3,3'-digallate, TF3)である。 However, there are few reports on the use of theaflavins from black tea extracts for oral hygiene. As a result of research, green tea catechins inhibit the growth of anaerobic bacteria and reduce the production of sulfides, thereby causing malodors, plaque formation, caries, and teeth including gingivitis and periodontitis. It has been found to delay the onset of perinatal disease. However, unlike green tea catechins, theaflavins in black tea are the most important active substances. These are important polyphenolic catechins (catechin (C), epigallocatechin (GC), epicatechin (EC), 3′-epicatechin gallate formed by oxidation or fermentation of natural pigments that are aromatics. (ECG), epigallocatechin gallocatechin (EGC), and epigallocatechin gallate (EGCG) etc.). They are more complex tea polyphenolic pigments that contain a benzotropolone molecular structure backbone. In the tea fermentation process, theaflavins (theaflavins, TF) and thearvidins (thearubigins, thearbins, TR) are formed by the oxidation of tea catechins. Traditionally, this oxidation process is called fermentation. Theaflavins and thealubidins give a unique color and aroma to tea. These theaflavins are mainly theaflavin (TF1), theaflavin-3-gallate (TF2a), theaflavin-3'-gallate (TF2b), and theaflavin- 3,3′-digallate (TF3).
本発明は、口臭および関連する口腔衛生の問題、例えば、歯肉炎、虫歯、歯周病、歯の過敏症の解消、口腔内の微生物バランスの維持について、治療および軽減するために口腔内で使用する組成物に関する。より具体的には、本発明では、口腔衛生に有効な量のテアフラビン類、有効な量の緩衝剤、約40乃至99質量%の1種または2種以上の薬学的に許容できる水溶性担体を含む組成物において、口腔用組成物の全水分含量が約5乃至20%である。本発明は、さらに紅茶を抽出することにより本発明の組成物を得る方法および本発明の組成物を使用する方法も含む。特に本発明の組成物は、人または動物の患者により、または患者のため、この組成物で口をうがいおよび/または洗浄することにより口臭や口腔内疾患を軽減するために使用される。 The present invention is used in the oral cavity to treat and reduce bad breath and related oral hygiene issues such as gingivitis, caries, periodontal disease, elimination of dental hypersensitivity, maintaining microbial balance in the oral cavity It relates to a composition. More specifically, in the present invention, an effective amount of theaflavins for oral hygiene, an effective amount of a buffering agent, about 40 to 99% by mass of one or more pharmaceutically acceptable water-soluble carriers. In the composition comprising, the total moisture content of the oral composition is about 5-20%. The present invention further includes a method of obtaining the composition of the present invention by extracting black tea and a method of using the composition of the present invention. In particular, the compositions of the present invention are used by human or animal patients or for patients to mitigate bad breath and oral diseases by gargleing and / or washing the mouth with this composition.
本明細書で使用する「有効な(投与)量」とは、悪臭を放つ細菌の増殖および生殖に対して検知できる程度の抑制をもたらし、それにより口臭を改善しおよび/または口腔内の歯垢の形成を抑制するために充分な投与量を意味する。 As used herein, an “effective (dose) amount” provides a detectable degree of control over the growth and reproduction of malodorous bacteria, thereby improving bad breath and / or plaque in the oral cavity. Means a dosage sufficient to inhibit the formation of.
本明細書で使用する「茶」は、ツバキ科ツバキ属の多年生の常緑樹に分類される植物(Camellia sinensis (L.) O. Kuntze)の葉を意味し、中国種茶、すなわち小葉(lobular)茶(Camellia sinensis var. Sinensis)およびプーアル茶葉(Camellia sinensis var. assamica)を含む。 As used herein, “tea” means leaves of plants (Camellia sinensis (L.) O. Kuntze) that are classified as perennial evergreens of the camellia family, Chinese tea, that is, lobular Contains tea (Camellia sinensis var. Sinensis) and puer tea leaves (Camellia sinensis var. Assamica).
本明細書で使用する「テアフラビン類」は、テアフラビン、イソテアフラビン、ネオテアフラビン、3−ガラートテアフラビン類、3’−ガラートテアフラビン類(theaflavin-3'-gallate)、3,3’−ジガラートテアフラビン類(teaflavin-3,3'-digalate)、エピテアフラビン酸(epitheaflavic acid)、3’−エピテアフラビン酸没食子酸エステル(epitheaflavic acid-3'-gallate)、茶のレチノイン酸(theaflavic acid)、茶の3’−レチノイン酸没食子酸エステル(theaflavic acid-3'-gallate)およびそれらの混合物を含むが、それらに限定される訳ではない。本明細書の「テアフラビン類」は、上記物質の塩も含む。 As used herein, “theaflavins” include theaflavin, isotheaflavin, neotheaflavin, 3-gallate theaflavins, 3′-galatotheaflavins (theaflavin-3′-gallate), 3,3′-digallate Theaflavins (teaflavin-3,3'-digalate), epitheaflavic acid, 3'-epitheaflavic acid gallate (epitheaflavic acid-3'-gallate), tea retinoic acid (theaflavic acid), tea 3'-retinoic acid gallate (theaflavic acid-3'-gallate) and mixtures thereof, but are not limited thereto. The “theaflavins” of the present specification includes salts of the above substances.
本発明の組成物は、練り歯磨き、歯磨き剤、口腔用スプレー、チューインガム、または持続放出タブレットの形状にすることができる。 The compositions of the present invention can be in the form of toothpastes, dentifrices, oral sprays, chewing gums, or sustained release tablets.
別に注釈しない限り、この記載における「歯磨剤」は、軟膏、ゲル状または液状の処方を意味する。 Unless otherwise noted, “dentifrice” in this description means an ointment, gel or liquid formulation.
オーラル(口腔用)組成物は、そのオーラルヘルスケアの目的を達成するために、口腔部の表面または口腔内に適用され、実質的に全ての歯の表面および/または口腔組織にそれが到達するために適切な時間内その場に留まる組成物を意味する。本発明のオーラルヘルスケア組成物は、人と動物の双方に対して有効に利用できる。 The oral (oral) composition is applied to the oral surface or oral cavity to achieve its oral health care objective, which reaches substantially all dental surfaces and / or oral tissues It means a composition that stays in place for a reasonable amount of time. The oral health care composition of the present invention can be effectively used for both humans and animals.
本明細書で使用する「水担体」は、本発明の組成物に適用するために、安全で有効な任意の水性物質を意味する。これらの物質は、研磨剤、過酸化物材料、重炭酸アルカリ金属塩、増粘剤、抗歯石剤、湿潤剤、水、界面活性剤、二酸化チタン、抗酸化剤、金属イオン、植物亜鉛、着色剤、香味料、キシリトール、エリスリトール、甘味料、ハーブ、保存剤、およびそれらの混合物を含む。 As used herein, “water carrier” means any aqueous material that is safe and effective for application to the compositions of the present invention. These substances are abrasives, peroxide materials, alkali metal bicarbonates, thickeners, anticalculus agents, wetting agents, water, surfactants, titanium dioxide, antioxidants, metal ions, plant zinc, coloring Including agents, flavoring agents, xylitol, erythritol, sweeteners, herbs, preservatives, and mixtures thereof.
本発明の組成物の活性成分は、茶のポリフェノール系カテキン類(カテキン(C)、エピガロカテキン(GC)、エピカテキン、ホルモン(EC)、3’−没食子酸、エピカテキン(ECG)、エピガロカテキン・ガロカテキン(EGC)、および3−エピ没食子カテキンガラートガラート(EGCG))から生成するテアフラビン類である。上記カテキン類は、紅茶に含まれ、紅茶の最も重要な活性物質であるベンゾトロポロン構造を有する茶のポリフェノール水酸化物に属する芳香族天然色素の酸化または発酵により得られる。茶の処理工程で、茶のカテキン類は酸化されて、テアフラビン類(theaflavins, TF)および茶の赤色色素(thearubins, TR)を生成する。伝統的には、これらの酸化処理を発酵と呼んでいる。テアフラビン類とテアルビン類は、紅茶に色と特有の香りを与えている。テアフラビン類は、テアフラビン(theaflavin, TF1)、テアフラビン−3−ガラート(theaflavin-3-gallate, TF2a)、テアフラビン−3’−ガラートガラート(theaflavin-3'-gallate, TF2b)、およびテアフラビン−3,3’−ビス没食子酸エステル(theaflavin-3,3'-digallate, TF3)を含む。その化学構造を図1に示す。本発明の組成物に用いる活性成分は、米国特許8282970号に記載の方法を用いて紅茶から抽出される。上記米国特許の内容の全ては、本明細書の記載とされる。 The active ingredients of the composition of the present invention include tea polyphenol catechins (catechin (C), epigallocatechin (GC), epicatechin, hormone (EC), 3′-gallic acid, epicatechin (ECG), epi These are theaflavins produced from gallocatechin and gallocatechin (EGC) and 3-epi gallic catechin gallate gallate (EGCG)). The catechins are contained in black tea and are obtained by oxidation or fermentation of aromatic natural pigments belonging to the polyphenol hydroxide of tea having a benzotropolone structure, which is the most important active substance of black tea. During tea processing, tea catechins are oxidized to produce theaflavins (TF) and red tea pigment (thearubins, TR). Traditionally, these oxidation treatments are called fermentation. Theaflavins and thearvins give color and a characteristic aroma to black tea. Theaflavins include theaflavin (TF1), theaflavin-3-gallate (TF2a), theaflavin-3'-gallate (TF2b), and theaflavin-3,3 '. -Contains bis gallate (theaflavin-3,3'-digallate, TF3). Its chemical structure is shown in FIG. The active ingredient used in the composition of the present invention is extracted from black tea using the method described in US Pat. No. 8,282,970. The entire contents of the above U.S. patents are incorporated herein.
[実施例1]
20%(TF20)、40%(TF40)および60%(TF60)の濃度で、テアフラビンTF1の3種類のサンプルを作製した。ここで、全ての濃度は質量%である。口内を発生源とする悪臭の原因として知られている下記の微生物を選択した:
トレポネーマ・デンティコラ;ポルフィロモナス・ジンジバリス;ポルフィロモナス・ジンジバリスのアエロモナス;黒色プレボテーラ(Black);プレボテーラ・インテルメディア;バクテロイデス・フォーサイス(Bacteroides forsythus);およびフソバクテリウム・ヌクレアタム。
歯肉下の歯垢と舌苔を集めて、非選択培地中に接種した。
[Example 1]
Three samples of theaflavin TF1 were prepared at concentrations of 20% (TF20), 40% (TF40) and 60% (TF60). Here, all the concentrations are mass%. The following microorganisms, which are known to cause malodor from the mouth, were selected:
P. gingivalis; Aeromonas of Porphyromonas gingivalis; Black Prevotella (Black); Prevotella intermedia; Bacteroides forsythus; and Fusobacterium nucleatum.
Subgingival plaque and tongue coating were collected and inoculated into non-selective medium.
(実験手順)
茶の抽出物を培地に加えて、サンプル1(TF20)の実験群、サンプル2(T40)の実験群、およびサンプル3(T60)の実験群に分割し、茶の抽出物を含まない対照培地も作製した。微生物をサンプルに加え、混合したものを嫌気性もしくは準嫌気性の条件下で培養した。培養で得られたコロニーを数え、各サンプル中の微生物の増殖の阻害の程度を決定した(単位:ppm)。
(Experimental procedure)
The tea extract is added to the medium and divided into the experimental group of sample 1 (TF20), the experimental group of sample 2 (T40), and the experimental group of sample 3 (T60), and the control medium does not contain the tea extract Also made. Microorganisms were added to the sample and the mixture was cultured under anaerobic or semi-anaerobic conditions. Colonies obtained from the culture were counted, and the degree of inhibition of the growth of microorganisms in each sample was determined (unit: ppm).
[実施例2]
(揮発性硫黄化合物(VSC)に対するテアフラビン類の効果)
テアフラビン抽出物のサンプルTF20、TF40およびTF60のそれぞれに、口臭を生じる細菌:ポルフィロモナス・ジンジバリス;アエロモナス;プレボテーラ・インテルメディア;およびフソバクテリウム・ヌクレアタムを加えた。各茶抽出物培地を実験群1(TF20)、実験群2(TF40)、および実験群3(TF60)に分割した。各実験群は、0.2%および1.0%の投与量の群に分割した。0.2%クロルヘキシジン溶液培地からなる陽性対照および抽出物を全く含まない対照も準備した。
[Example 2]
(Effect of theaflavins on volatile sulfur compounds (VSC))
To each of the theaflavin extract samples TF20, TF40, and TF60 were added bacteria that produce bad breath: Porphyromonas gingivalis; Aeromonas; Prevoterra intermedia; and Fusobacterium nucleatum. Each tea extract medium was divided into experimental group 1 (TF20), experimental group 2 (TF40), and experimental group 3 (TF60). Each experimental group was divided into 0.2% and 1.0% dose groups. A positive control consisting of 0.2% chlorhexidine solution medium and a control without any extract were also prepared.
各実験群、陽性対照群、およびブランク対照群に、上記の細菌を接種し、嫌気性条件下、37℃で7時間培養し、揮発性硫黄化合物(VSC)のレベルを、呼気測定器(ハリメーター)を用いて測定した。 Each experimental group, positive control group, and blank control group were inoculated with the above-mentioned bacteria, cultured at 37 ° C. for 7 hours under anaerobic conditions, and the level of volatile sulfur compounds (VSC) was measured with an exhalation meter (harness). Meter).
以下の処方物を作製した(以下の%は全て質量%であり、処方物の全質量に基づく値である)。 The following formulations were made (all percentages below are% by weight and are values based on the total weight of the formulation):
処方物1:
リン酸水素2水和物45%;二酸化ケイ素2%;グリセロール10%;ソルビトール10%;カルボキシメチルセルロース;オゴノリ(Gracilaria)0.3;ラウリル硫酸ナトリウム16.8%;精製水28.9%;香味料1%;甘味料。
Formulation 1:
Hydrogen phosphate dihydrate 45%; Silicon dioxide 2%; Glycerol 10%; Sorbitol 10%; Carboxymethyl cellulose; Gracilaria 0.3; Sodium lauryl sulfate 16.8%; Purified water 28.9%; Flavor 1%; sweetener.
処方物2:
フッ化第一スズ0.2%;ピロリン酸カルシウム39%;グリセロール10%;ソルビトール20;ピロリン酸第一スズ、粘着剤、香味料、および発泡剤4.6%;精製水25%。
Formulation 2:
Stannous fluoride 0.2%; calcium pyrophosphate 39%; glycerol 10%; sorbitol 20; stannous pyrophosphate, adhesives, flavors, and blowing agents 4.6%; purified water 25%.
処方物3:
モノフルオロリン酸ナトリウム0.76%;不溶性メタリン酸ナトリウム42%;リン酸二カルシウム2水和物;水酸化アルミニウム1%;湿潤剤;アイリッシュモス抽出物1%;二酸化チタン0.4%;ベンゼンナトリウム0.5%;N−ラウロイルサルコシンナトリウム;香味料;100%とするための精製水。
Formulation 3:
Sodium monofluorophosphate 0.76%; insoluble sodium metaphosphate 42%; dicalcium phosphate dihydrate; aluminum hydroxide 1%; wetting agent; Irish moss extract 1%; titanium dioxide 0.4%; Benzene sodium 0.5%; N-lauroyl sarcosine sodium; flavor; purified water to make 100%.
処方物4:
N−ラウロイルサルコシンナトリウム;ラウリル硫酸ナトリウム0.5%;アルギン酸ナトリウム0.9%;蛋白質分解酵素(ペースト、グラム当たり1500〜2000単位);100%とするための精製水。
Formulation 4:
N-lauroyl sarcosine sodium; sodium lauryl sulfate 0.5%; sodium alginate 0.9%; proteolytic enzyme (paste, 1500-2000 units per gram); purified water to make 100%.
処方物5:
四級アンモニウム塩0.5%;非イオン界面活性剤2%;グリセロール22%;CMC0.85%;ピロリン酸ナトリウム;サッカリン0.2%;安息香酸ナトリウム0.5%;沈降カルバミン酸カルシウム5%;DCP2水和物46.8%;香味料0.8%;精製水21.1%。
Formulation 5:
Quaternary ammonium salt 0.5%; Nonionic surfactant 2%; Glycerol 22%; CMC 0.85%; Sodium pyrophosphate; Saccharin 0.2%; Sodium benzoate 0.5%; Precipitated calcium carbamate 5% DCP dihydrate 46.8%; flavoring 0.8%; purified water 21.1%.
処方物6:
硝酸カリウム10%;グリセロール25%;グリコールセルロースエーテル1.6%;モノラウリン酸ポリオキシメチレン・ソルビタン;シリカ24%;ハッカ油1%;サッカリン0.2%;100%とするための精製水。
Formulation 6:
Purified water to make potassium nitrate 10%; glycerol 25%; glycol cellulose ether 1.6%; polyoxymethylene sorbitan monolaurate; silica 24%; mint oil 1%; saccharin 0.2%;
処方物7:
塩化ナトリウム15%;ヒドロキシエチルセルロース;コロイド状シリカ2.5%;グリセロール5%;エチレンオキシド%;プロピレンオキシドブロック共重合体0.5%;亜リン酸カルシウム30%;サッカリン0.3%;100%とするための精製水。
Formulation 7:
Sodium chloride 15%; hydroxyethyl cellulose; colloidal silica 2.5%; glycerol 5%; ethylene oxide%; propylene oxide block copolymer 0.5%; calcium phosphite 30%; saccharin 0.3%; Purified water.
[実施例3]
(口腔洗浄液の処方)
組成物:
クロルヘキシジン2g;メトロニダゾール2g;ハッカ油0.5ml;トゥイーン−80(1ml);サッカリンナトリウム;1000mlとするための蒸留水。
[Example 3]
(Prescription of mouthwash)
Composition:
Chlorhexidine 2 g; metronidazole 2 g; mint oil 0.5 ml; tween-80 (1 ml); saccharin sodium; distilled water to make 1000 ml.
調製方法:
クロルヘキシジンとメトロニダゾールを適量の蒸留水に溶解し、ハッカ油とトゥイーン80を加え、完全に混合して熱した蒸留水中に溶かし、サッカリンナトリウムを加え、完全に溶解するまで攪拌して濾過した。蒸留水をフィルターに加え、良く攪拌した。
Preparation method:
Chlorhexidine and metronidazole were dissolved in an appropriate amount of distilled water, mint oil and Tween 80 were added, thoroughly mixed and dissolved in heated distilled water, saccharin sodium was added, and the mixture was stirred and dissolved until completely dissolved. Distilled water was added to the filter and stirred well.
[実施例4]
組成物 態様A 態様B
テアフラビン類(TF60) 10g 5g
トゥイーン−80 1ml 1ml
ハッカ 0.5ml 0.5ml
リン酸緩衝液 10ml 10ml
精油 0.1ml 0.1ml
着色料 100mg 100mg
保存料 50mg 50mg
脱イオン水 1000ml 1000ml
[Example 4]
Composition Aspect A Aspect B
Theaflavins (TF60) 10g 5g
Tween-80 1ml 1ml
Mint 0.5ml 0.5ml
Phosphate buffer solution 10ml 10ml
Essential oil 0.1ml 0.1ml
Coloring agent 100mg 100mg
Preservative 50mg 50mg
Deionized water 1000ml 1000ml
[実施例5]
(チューインガム)
組成物 態様C 態様D
テアフラビン類(TF60) 10g 5g
トゥイーン−80 1ml 1ml
ハッカ 0.5ml 0.5ml
リン酸緩衝液 10ml 10ml
精油 0.1ml 0.1ml
着色料 100mg 100mg
保存料 50mg 50mg
脱イオン水 1000ml 1000ml
[Example 5]
(Chewing gum)
Composition Aspect C Aspect D
Theaflavins (TF60) 10g 5g
Tween-80 1ml 1ml
Mint 0.5ml 0.5ml
Phosphate buffer solution 10ml 10ml
Essential oil 0.1ml 0.1ml
Coloring agent 100mg 100mg
Preservative 50mg 50mg
Deionized water 1000ml 1000ml
[実施例6]
(多層持続放出バッカル錠剤)
組成物 態様E 態様F
テアフラビン類(TF60) 10g 5g
トゥイーン−80 1ml 1ml
ハッカ 0.5ml 0.5ml
リン酸緩衝液 10ml 10ml
精油 0.1ml 0.1ml
着色料 100mg 100mg
保存料 50mg 50mg
脱イオン水 1000ml 1000ml
[Example 6]
(Multilayer sustained release buccal tablets)
Composition Aspect E Aspect F
Theaflavins (TF60) 10g 5g
Tween-80 1ml 1ml
Mint 0.5ml 0.5ml
Phosphate buffer solution 10ml 10ml
Essential oil 0.1ml 0.1ml
Coloring agent 100mg 100mg
Preservative 50mg 50mg
Deionized water 1000ml 1000ml
[実施例7]
この例では、ハリメーターを使用し、以下の異常判別基準に従い選択した患者について7種の組成物による健康状態抑制効果を試験した:
ハリメーター値(揮発性硫黄の濃度)≧200×103ml/m3;
耳鼻咽喉、消化器、呼吸器およびその他の全身性疾患の徴候がないこと;
口内を原因とする健康状態に異常を来す要素が除外されていること;
実験前に口内で抗生物質を使用したことによる深刻な粘膜疾患が存在しないこと;
および
迎合性が低いこと。
チュー・ホアンチョー(Zhu Huanzhe)は、試験組成物を使用する前の24時間以内に、芳香性飲料、化粧品、および口内洗浄液の使用を検査し;試験前に、にんにく、ねぎ、にんじんその他の硫黄含有量が高い食物を摂取していないかを検査し;午前7:00〜12:00の間で、歯を磨き、口をすすぐ前に息を調べ、6時間前から何も食べていないことを確認した。
[Example 7]
In this example, a halimeter was used to test the health-inhibiting effect of seven compositions on patients selected according to the following criteria for abnormality determination:
Halimeter value (concentration of volatile sulfur) ≧ 200 × 10 3 ml / m 3 ;
No signs of ENT, digestive, respiratory and other systemic illnesses;
The exclusion of factors that cause abnormal health conditions in the mouth;
The absence of serious mucosal disease due to the use of antibiotics in the mouth before the experiment;
And low compliance.
Zhu Huanze examines the use of aromatic beverages, cosmetics, and mouthwashes within 24 hours before using the test composition; contains garlic, green onions, carrots and other sulfur-containing products prior to testing Check for high-dose food; between 7:00 am and 12:00 am, brush your teeth, check your breath before you rinse your mouth, and do not eat anything for 6 hours confirmed.
上記基準に従い125名の患者を選別し、それぞれをランダムに5グループに振り分け、0.4%T20、0.4%T40、0.4%T60と呼ぶ練り歯磨きを用いて歯磨き後、消臭剤を用い、特定の練り歯磨きと歯ブラシを用いた。ブラッシング後、被験者を1分間隔離して、呼気測定器(ハリメーター)を気管に向けて約4cm入れた。鼻呼吸で検出処理を行い、0、1、2、3、4、および5時間後に呼気中の揮発性硫化物濃度のピークを記録した。各患者に関する呼気の試験記録は、洗浄後の値を採用した。二重読み取りを行った。SPSS統計ソフトウェアを実験結果の処理と分析に使用し、二つのグループの間で対にしてテイ(t)試験を行うことにより自己対照とした。 125 patients were selected according to the above criteria, and each was randomly assigned to 5 groups. After brushing with toothpaste called 0.4% T20, 0.4% T40, 0.4% T60, deodorant Using a specific toothpaste and toothbrush. After brushing, the subject was isolated for 1 minute, and an expiration meter (halimeter) was placed about 4 cm toward the trachea. The detection process was performed by nasal breathing, and the peak of volatile sulfide concentration in the breath was recorded after 0, 1, 2, 3, 4, and 5 hours. The exhalation test records for each patient were taken after washing. A double reading was performed. SPSS statistical software was used to process and analyze the experimental results and was self-control by performing paired (t) tests between the two groups.
[実施例8]
男性X例、女性X例の口を原因とする口臭患者の呼気について、N例の確認を行った。各患者の条件は、以下の通りである:
18歳以上;全体として健康であること;非喫煙者であること;少なくとも20本の本来の歯を持っていること;少なくとも6ヶ月以内に歯周関係の治療を受けていないこと;補助具を取り付けていないこと、顕著に不都合な歯の修復、虫歯および食片圧入がないこと、並びに粘膜疾患がないこと;一ヶ月の期間内で二週間抗生物質を使用せず、三日間以上連続して抗生物質を使用しなかったこと;女性の場合、月経期間、妊娠、授乳のいずれでもないこと。
当該患者は、インフォームドコンセントの書類に署名した。
[Example 8]
N cases were confirmed for the breath of bad breath patients caused by mouths of male X cases and female X cases. The conditions for each patient are as follows:
18 years of age or older; overall healthy; non-smoker; at least 20 original teeth; no periodontal treatment within at least 6 months; No attachment, markedly inconvenient dental restoration, absence of dental caries and food fragments, and no mucosal disease; no antibiotics used for 2 weeks within 1 month, 3 consecutive days or more Not using antibiotics; for women, neither menstrual period, pregnancy, nor breastfeeding.
The patient signed an informed consent document.
(実験条件と処理)
試験前の二日間は,たばことアルコールを禁止した。試験前の1日以内では、にんにく、タマネギ、ねぎ、だいこん、その他の食物の摂取と芳香性の高い化粧品の使用も禁止した。朝、被験者を、歯を磨くことなく、食事を取らず、口内洗浄液、チューインガム、コーヒーその他の飲料を使用することのない状態で検査した。試験は、良く換気した無臭の室内で実施した。状態の確認の全ては、経験を積んだ臭覚技術者が行った。
(Experimental conditions and treatment)
Tobacco and alcohol were banned for two days before the test. Within one day before the test, intake of garlic, onion, green onion, daiko and other foods and the use of highly aromatic cosmetics were also prohibited. In the morning, subjects were examined without brushing their teeth, eating meals, and not using mouth washes, chewing gum, coffee or other beverages. The test was conducted in a well-ventilated and odorless room. All confirmation of the condition was performed by experienced olfactory engineers.
1)口内洗浄液の使用
適切な基準に従いXXを伴う患者の呼気の異常の検出を、それぞれランダムに5グループに振り分け、0.4%T20、0.4%T40、0.4%T60と呼ぶ口内洗浄液でうがいをし、15mlの蒸留水で1分間口内洗浄した。被験者を1分間隔離して、呼気測定器(ハリメーター)を気管に向けて口内に約4cm入れた。鼻呼吸で検出処理を行い、0、1、2、3、4、5、および6時間後に呼気中の揮発性硫化物濃度のピークを記録した。各患者に関する呼気の試験記録では洗浄後の値を採用し、各時間の値は二重に検出し、いずれも平均値を得た。
1) Use of mouth washing solution According to appropriate criteria, detection of abnormal breaths in patients with XX is randomly assigned to 5 groups, called 0.4% T20, 0.4% T40, 0.4% T60. Gargle with the washing solution and rinse in the mouth with 15 ml of distilled water for 1 minute. The subject was isolated for 1 minute, and about 4 cm was placed in the mouth with a breath meter (halimeter) facing the trachea. The detection process was performed by nasal breathing, and the peak of volatile sulfide concentration in the breath was recorded after 0, 1, 2, 3, 4, 5, and 6 hours. The exhalation test records for each patient employed post-wash values, each time value was detected in duplicate, and average values were obtained for each.
[実施例9]
(チューインガム)
上記の適切な基準を用いて呼気の異常の検出を行った。患者は、ランダムに5グループに振り分け、0.4%T20、0.4%T40、0.4%T60と呼ぶチューインガムを5分間噛んだ。ガムを噛んだ後、被験者の口を1分間閉じて、呼気測定器(ハリメーター)を気管に向けて約4cm入れた。鼻呼吸で検出処理を行い、0、1、2、3、4、5、および6時間後に呼気中の揮発性硫化物濃度のピークを記録した。各患者に関する呼気の試験記録では、洗浄後の値を採用した。二重読み取りを行った。SPSS統計ソフトウェアを実験結果の処理と分析に使用し、二つのグループの間で対にしてテイ(T)試験することにより自己対照とした。
[Example 9]
(Chewing gum)
Exhalation abnormalities were detected using the appropriate criteria described above. The patients were randomly assigned to 5 groups and chewing gums called 0.4% T20, 0.4% T40, 0.4% T60 for 5 minutes. After chewing the gum, the subject's mouth was closed for 1 minute, and an expiration meter (halimeter) was placed about 4 cm toward the trachea. The detection process was performed by nasal breathing, and the peak of volatile sulfide concentration in the breath was recorded after 0, 1, 2, 3, 4, 5, and 6 hours. In the expiratory test record for each patient, the value after washing was adopted. A double reading was performed. SPSS statistical software was used to process and analyze the experimental results and was self-control by pairing (T) testing between the two groups.
被験者を1分間隔離して、呼気測定器(ハリメーター)を気管に向けて口内約4cmに入れた。鼻呼吸で検出処理を行い、0、1、2、3、4、5、および6時間後に呼気中の揮発性硫化物濃度のピークを記録した。各患者に関する呼気の試験記録では洗浄後の値を採用し、各時間の値は二重に検出し、いずれも平均値を得た。 The subject was isolated for 1 minute, and the breath measuring device (halimeter) was placed about 4 cm in the mouth with the trachea facing. The detection process was performed by nasal breathing, and the peak of volatile sulfide concentration in the breath was recorded after 0, 1, 2, 3, 4, 5, and 6 hours. The exhalation test records for each patient employed post-wash values, each time value was detected in duplicate, and average values were obtained for each.
[実施例10]
(多層持続放出バッカル錠剤)
適切な基準に従い患者の呼気の異常の検出を、それぞれランダムに5グループに振り分け、0.4%T20、0.4%T40、0.4%T60として錠剤を投与した。被験者の口を1分間閉じて、呼気測定器(ハリメーター)を気管に向けて約4cm入れた。鼻呼吸で検出処理を行い、0、1、2、3、4、5、および6時間後に呼気中の揮発性硫化物濃度のピークを記録した。各患者に関する呼気の試験記録では、洗浄後の値を採用した。二重読み取りを行った。SPSS統計ソフトウェアを実験結果の処理と分析に使用し、二つのグループの間で対にしてテイ(t)試験することにより自己対照とした。
[Example 10]
(Multilayer sustained release buccal tablets)
Detection of abnormalities in exhalation of patients according to appropriate criteria was randomly assigned to 5 groups, and tablets were administered as 0.4% T20, 0.4% T40, 0.4% T60. The subject's mouth was closed for 1 minute, and an expiration meter (halimeter) was inserted about 4 cm toward the trachea. The detection process was performed by nasal breathing, and the peak of volatile sulfide concentration in the breath was recorded after 0, 1, 2, 3, 4, 5, and 6 hours. In the expiratory test record for each patient, the value after washing was adopted. A double reading was performed. SPSS statistical software was used to process and analyze experimental results and was self-control by pairing (t) testing between the two groups.
(実験結果)
テアフラビン類は、口臭(揮発性硫化物濃度)を生じる細菌の口内での増殖に対して有効である。
(Experimental result)
Theaflavins are effective against the growth of bacteria that produce bad breath (volatile sulfide concentration) in the mouth.
1.実験グループ
対照:嫌気性ボックス内での揮発性硫黄化合物(Volatile Sulfur Compound: VSC)の気体濃度を培養器環境におけるVSCの背景濃度とみなすことができる。
陰性対照:VSCを抑制するいずれの物質も使用しない以外は、陽性対照およびサンプル群の菌株と同じである。
陽性対照:クロルヘキシジンを抑制効果の陽性の参照とした。
テアフラビン類:テアフラビン類のサンプルを、20%、40%、および60%の純度に従って含むサンプルである。
実際値:陰性対照、陽性対照およびサンプルのデータから対照の値を引いたものがデータの数値である。
1. Experimental group Control: The gas concentration of volatile sulfur compounds (VSC) in an anaerobic box can be considered as the background concentration of VSC in the incubator environment.
Negative control: Same as the positive control and sample group strains, except that no substance that suppresses VSC is used.
Positive control: Chlorhexidine was used as a positive reference for inhibitory effect.
Theaflavins: Samples containing samples of theaflavins according to 20%, 40%, and 60% purity.
Actual value: Negative control, positive control and sample data minus control value is the data value.
2.使用した実験菌株
口臭を生じる性質を有する細菌(Fnの標準株およびPgの標準株)
2. Experimental strains used Bacteria that produce halitosis (standard strain of Fn and standard strain of Pg)
3.結果
標準菌株FnによるVSC生成に対する抑制効果
3. Results Inhibitory effect on VSC production by standard strain Fn
標準菌株PgによるVSC生成に対する抑制効果 Inhibitory effect on VSC production by standard strain Pg
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CN114392212A (en) * | 2021-12-10 | 2022-04-26 | 江苏德和生物科技有限公司 | Theaflavin composition, preparation method and application |
CN115486310B (en) * | 2022-09-15 | 2024-01-09 | 中国农业科学院茶叶研究所 | Planting and processing method of low-fluorine black tea |
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JPS60153778A (en) * | 1984-01-19 | 1985-08-13 | Lotte Co Ltd | Deodorizing composition and foul breath eliminating cake containing said composition |
JP2000178157A (en) * | 1998-12-18 | 2000-06-27 | Mitsui & Co Ltd | Mouth spray composition |
WO2001017494A1 (en) * | 1999-09-08 | 2001-03-15 | The Procter & Gamble Company | Oral compositions comprising tea polyphenol |
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JPS60153778A (en) * | 1984-01-19 | 1985-08-13 | Lotte Co Ltd | Deodorizing composition and foul breath eliminating cake containing said composition |
JP2000178157A (en) * | 1998-12-18 | 2000-06-27 | Mitsui & Co Ltd | Mouth spray composition |
WO2001017494A1 (en) * | 1999-09-08 | 2001-03-15 | The Procter & Gamble Company | Oral compositions comprising tea polyphenol |
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