CN111698996A - 用于牙科组合物的氟化银溶液 - Google Patents

用于牙科组合物的氟化银溶液 Download PDF

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Publication number
CN111698996A
CN111698996A CN201980012753.5A CN201980012753A CN111698996A CN 111698996 A CN111698996 A CN 111698996A CN 201980012753 A CN201980012753 A CN 201980012753A CN 111698996 A CN111698996 A CN 111698996A
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silver fluoride
silver
solution
aqueous
solutions
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CN201980012753.5A
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P·法勒
A·塔吉特
M·罗
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SDI Ltd
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SDI Ltd
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Priority claimed from AU2018900432A external-priority patent/AU2018900432A0/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/38—Silver; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/16—Fluorine compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/20—Halogens; Compounds thereof
    • A61K8/21—Fluorides; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
    • A61K2800/52—Stabilizers

Abstract

本发明涉及一种具有pH为4.0‑5.3的含氟化银(AgF)的水溶液。

Description

用于牙科组合物的氟化银溶液
技术领域
本发明涉及一种用于牙科组合物的氟化银溶液。
背景技术
多年来已知含氟化银产品可提供作为一种治疗牙齿硬组织的方法。溶液一般以氟化银(AgF)、硝酸银(AgNO3)或氟化二胺银(SDF)的水溶液形式提供。具体地，已知这些产品通过杀死与龋齿相关的细菌然后促进脱矿胶原的再矿化来保护受影响的牙齿。此外，这些产品还可用于通过阻塞流体通过牙质小管的运动来降低牙齿敏感性。
含有氟化银的产品具有由于银离子的氧化而将受龋齿影响的牙齿的颜色改变为永久黑色色调的共同缺点。如果与含有氟化银的溶液接触，口腔软组织(牙龈、面颊、嘴唇等)也会变黑，尽管这仅仅是暂时的并且在之后的几天内逐渐消失。
缓解黑色染色的一种方法是将含氟化银的产品与随后的含碘化物盐的溶液一起使用，当在含氟化银的溶液之后立即施用时，所述含碘化物盐的溶液容易与游离银离子反应，形成不溶于水的、奶油色的碘化银盐。在该治疗方法之后，龋齿损伤现在将显示淡褐色(而不是黑色)，并且其它牙质组织(非龋齿、齿龈等)将在过量的碘化银盐被冲洗掉时不发生改变。
由于以下原因，含氟化银的溶液在储存时通常表现出较差的稳定性。
(1)AgF溶液在储存时倾向于从溶液中沉淀出来。沉淀物倾向于在内表面上形成为层和/或沉降到储存容器(例如瓶)的底部。因此，可溶性离子浓度的降低导致了牙齿治疗的有效性减少。
(2)可以通过加入氨以形成氟化二氨银(SDF)来稳定AgF溶液。氨与银离子结合产生称为二氨银离子[Ag(NH3)2]+的络离子。这是可逆反应，但是络合物非常稳定。然而，由于氨的高挥发性，含氨组合物难以储存。瓶和容器在储存时容易损失氨，特别是在高温下，导致剩余的AgF溶液变得不稳定(导致沉淀)。
用于制备稳定的银络合物的氨导致许多商业产品中pH升高至危险水平(pH＞10)。而且(由于氨的挥发性)难以长期储存，遗憾的是，更为稳定的SDF溶液对口腔软组织非常刺激，并且如果任其长时间接触的话，可能导致化学灼伤。
发明内容
开发一种储存稳定的含氟化银的溶液是有利的，该溶液表现出龋齿抑制和牙齿脱敏，同时对口腔软组织温和。合适的体系是基于在pH4-5.3范围内稳定的基本上为水性的氟化银溶液。
本发明的稳定的氟化银溶液也适合与含碘化物盐的溶液一起使用，以减少如上所述的染色。
具体实施方式
为了降低SDF溶液的pH值，不使用氨，得到氟化银水溶液。新鲜制备的38％w/v氟化银水溶液通常具有6.2-6.4的pH，其在储存时不稳定并且银开始从溶液中沉淀出来。通过用酸将溶液的pH调节至4.0-5.3的pH，实现溶液的稳定性。pH值在4.0以下被认为是不合适的，因为这可能由于酸性溶液的腐蚀性而引起化学灼伤和刺激。pH值在5.3以上对于长期贮存来说是不稳定的，银会从溶液中沉淀出来。硝酸是用作酸性pH调节剂的优选化合物，然而也可以使用形成可溶性银盐的其它有机或无机酸。这避免了作为反应产物的不可溶的银盐沉淀。
实施例
制备三种含水的38％(w/v)氟化银产品，每种溶液显示不同的pH。测试产物的性能属性，详见表1。
表1
Figure BDA0002627075870000031
*水力传导(Lp％)用于确定通过牙质小管的流体运动的减少(0％-无闭塞，100％-完全闭塞，无流体运动)。通过牙质小管的流体运动可能是牙齿过敏症的原因，因此Lp％代表脱敏作用。将第二步的应用(碘化钾溶液)用于所有实施例产品，以测试不同的氟化银溶液是否会形成碘化银沉淀封闭牙质小管。
结论
实施例1：储存稳定性好，牙质小管封闭性好，生物相容的pH值(无软组织刺激)。
对比例1：储存稳定性差，牙质小管封闭性好，生物相容的pH值(无软组织刺激)。
对比例2：储存稳定性好，牙质小管封闭性好，生物不相容的pH值(软组织刺激)。
对于本领域技术人员显而易见的修改和变化被认为在本发明的范围内。

Claims (5)

1.一种pH4.0-5.3的含氟化银(AgF)的水溶液。
2.根据权利要求1所述的氟化银水溶液，其中，组合物通过酸稳定。
3.根据权利要求2所述的氟化银水溶液，其中，所述酸为硝酸。
4.根据权利要求1所述的氟化银水溶液，其中，氟化银的含量为0-50％w/v。
5.根据权利要求1所述的氟化银水溶液，其中，后续可选择性地应用含碘溶液用于减少染色。
CN201980012753.5A 2018-02-12 2019-02-07 用于牙科组合物的氟化银溶液 Pending CN111698996A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
AU2018900432 2018-02-12
AU2018900432A AU2018900432A0 (en) 2018-02-12 Silver fluoride solutions for dental compositions
PCT/AU2019/000014 WO2019153033A1 (en) 2018-02-12 2019-02-07 Silver fluoride solutions for dental compositions

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Cited By (1)

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WO2023016544A1 (en) * 2021-08-13 2023-02-16 The University Of Hong Kong Silver complex fluoride {bis (1, 3, 5-triaza-7-phosphaadamantane) silver fluoride} -a new therapeutic agent for caries management

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2610009B (en) 2022-02-28 2023-11-08 R And K Bedi Ltd Stable compositions for the treatment of dental caries

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CH480841A (de) * 1965-02-10 1969-11-15 Procter & Gamble Zahnpflegemittel
DE3530375C1 (de) * 1985-08-24 1986-12-18 Degussa Ag, 6000 Frankfurt Verfahren zur Herstellung von Silber (II, III)-oxid
CN106900991A (zh) * 2015-12-22 2017-06-30 青岛城轨交通装备科技有限公司 饲料酸度调节剂
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CH480841A (de) * 1965-02-10 1969-11-15 Procter & Gamble Zahnpflegemittel
DE3530375C1 (de) * 1985-08-24 1986-12-18 Degussa Ag, 6000 Frankfurt Verfahren zur Herstellung von Silber (II, III)-oxid
CN106900991A (zh) * 2015-12-22 2017-06-30 青岛城轨交通装备科技有限公司 饲料酸度调节剂
CN106974834A (zh) * 2017-04-01 2017-07-25 首都医科大学附属北京口腔医院 一种利用延迟反应在牙本质小管内形成矿物质的材料及其应用

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023016544A1 (en) * 2021-08-13 2023-02-16 The University Of Hong Kong Silver complex fluoride {bis (1, 3, 5-triaza-7-phosphaadamantane) silver fluoride} -a new therapeutic agent for caries management

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EP3752169A1 (en) 2020-12-23
AU2019217656B2 (en) 2021-08-19
AU2019217656C1 (en) 2023-02-16
JP7308212B2 (ja) 2023-07-13
US20220218743A1 (en) 2022-07-14
WO2019153033A1 (en) 2019-08-15
AU2019217656A1 (en) 2020-09-03
JP2021513510A (ja) 2021-05-27

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