Indicator and dental instrument with controlled release preparation

Abstract

The present invention discloses an indicator with a controlled release preparation and a dental instrument, wherein the indicator comprises an indicator layer with a controlled release preparation, and the indicator layer reacts under the action of an agent in the oral cavity. The present invention can control the reaction rate of the indicator layer by means of the controlled release preparation, and can greatly improve the accuracy of the wearing time indicated by the indicator, thereby improving the indication effect of the indicator.

Description

Technical Field

[0001] The present invention relates to the technical field of dental correction, and in particular to an indicator and a dental instrument with a controlled-release preparation. Background Art

[0002] In the field of dentistry, many treatments need to be completed by wearing dental instruments in the mouth, such as orofacial muscle training devices and shell-shaped appliances based on polymer materials, which are becoming increasingly popular due to their advantages such as beauty, convenience and easy cleaning.

[0003] During the treatment process, sufficient wearing time of dental appliances is an important guarantee for treatment. However, due to the discomfort during wearing and the fact that dental appliances can be removed at any time, patient compliance is a problem that troubles clinicians.

[0004] Therefore, suitable means are needed to improve patient compliance on the one hand and to indicate whether the dental appliance has been worn for a sufficient period of time on the other hand.

[0005] In the prior art, an indicator can be used in the oral cavity to indicate the wearing time, but there is a problem of poor indication effect. Summary of the invention

[0006] The object of the present invention is to provide an indicator and a dental instrument with a controlled-release preparation, wherein the indicator can improve the indicating effect.

[0007] To achieve one of the above-mentioned purposes, an embodiment of the present invention provides an indicator with a controlled release agent for use in dental instruments, wherein the indicator comprises an indicator layer with a controlled release agent, wherein the indicator layer reacts under the action of an agent in the oral cavity.

[0008] As a further improvement of one embodiment of the present invention, the controlled-release preparation is used to control the indicator layer to maintain a constant reaction rate.

[0009] As a further improvement of one embodiment of the present invention, the indicator layer further includes a functional agent, and the indicator layer releases the functional agent under the action of an agent in the oral cavity.

[0010] As a further improvement of one embodiment of the present invention, the functional agent is evenly distributed in the indicator layer.

[0011] As a further improvement of one embodiment of the present invention, the functional preparation is a breath freshening preparation and / or a pharmaceutical preparation.

[0012] As a further improvement of an embodiment of the present invention, the indicator layer displays a pattern under the action of an agent in the oral cavity.

[0013] As a further improvement of an embodiment of the present invention, the indicator layer displays a pattern through changes in volume, shape, color, pattern or morphology.

[0014] As a further improvement of one embodiment of the present invention, the controlled-release preparation swells under the action of an agent in the oral cavity to control the display pattern of the indicator layer.

[0015] As a further improvement of an embodiment of the present invention, the indicator layer displays a pattern by increasing its volume.

[0016] As a further improvement of an embodiment of the present invention, the indicator layer includes edible pigments, and the indicator layer displays patterns through color changes.

[0017] As a further improvement of one embodiment of the present invention, the indicator layer includes a first layer and a second layer stacked together, the first layer has a first color, and the controlled-release preparation swells under the action of an agent in the oral cavity to control the first color to gradually penetrate into the second layer.

[0018] As a further improvement of an embodiment of the present invention, the indicator further includes a packaging layer encapsulating the indicating layer, and the packaging layer is elastic.

[0019] As a further improvement of an embodiment of the present invention, the encapsulation layer is a transparent layer.

[0020] As a further improvement of an embodiment of the present invention, the indication layer further includes a filling material and an adhesive material.

[0021] As a further improvement of one embodiment of the present invention, the indicator layer further includes at least one of a lubricant, a disintegrant, an edible flavor and an edible coloring.

[0022] As a further improvement of one embodiment of the present invention, the controlled release preparation is a skeleton-type controlled release preparation, a membrane-controlled release preparation or an osmotic pump controlled release preparation.

[0023] As a further improvement of one embodiment of the present invention, the indicator layer is a tablet, and the thickness of the indicator layer ranges from 0.01 mm to 5 mm.

[0024] As a further improvement of an embodiment of the present invention, the indicator further comprises a packaging layer encapsulating the indicator layer, and the packaging layer has a through hole connecting the indicator layer and the oral cavity.

[0025] As a further improvement of an embodiment of the present invention, the indicator further includes a flow control layer located between the indicator layer and the oral cavity, and the flow control layer is used to control the rate at which the agent in the oral cavity enters the indicator layer.

[0026] As a further improvement of an embodiment of the present invention, the flow control layer is a transparent layer.

[0027] As a further improvement of an embodiment of the present invention, the indicator layer reacts to generate a change area, and the indicator further includes a scale area, and the scale area is used to indicate position information of the change area.

[0028] To achieve one of the above objects of the invention, an embodiment of the present invention provides a dental instrument for being worn in the oral cavity, comprising an indicator as described in any one of the above technical solutions.

[0029] As a further improvement of an embodiment of the present invention, the dental instrument comprises a dental instrument body and an indicator arranged on the dental instrument body, and the dental instrument body forms a cavity for accommodating teeth.

[0030] As a further improvement of an embodiment of the present invention, the indicator is arranged on a side of the dental instrument body close to the tongue side, and / or the indicator is arranged on a side of the dental instrument body close to the labial side.

[0031] As a further improvement of one embodiment of the present invention, the dental instrument is a shell-shaped orthodontic appliance or an orofacial muscle trainer.

[0032] Compared with the prior art, the beneficial effect of one embodiment of the present invention is that the reaction rate of the indicator layer can be controlled by means of a controlled-release preparation, which can greatly improve the accuracy of the wearing time indicated by the indicator, thereby improving the indication effect of the indicator. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 is a schematic diagram of a dental apparatus according to an embodiment of the present invention;

[0034] Figure 2 is a schematic diagram of an indicator according to an embodiment of the present invention;

[0035] Figure 3 Schematic diagram of an indicator layer formed by the cooperation of a semipermeable membrane and a tablet core according to one embodiment of the present invention;

[0036] Figure 4 is a schematic diagram of an indicator with an encapsulation layer according to an embodiment of the present invention;

[0037] Figure 5 is a schematic diagram of the color and volume changes of the indicator when the controlled-release preparation according to one embodiment of the present invention swells;

[0038] Figure 6 It is a schematic diagram of an indicator with a packaging layer and a flow control layer according to an embodiment of the present invention. DETAILED DESCRIPTION

[0039] The present invention will be described in detail below in conjunction with the specific embodiments shown in the accompanying drawings. However, these embodiments do not limit the present invention, and any structural, methodological, or functional changes made by a person skilled in the art based on these embodiments are all within the scope of protection of the present invention.

[0040] Combination Figure 1 and Figure 2 , a dental instrument 100 and an indicator 10 according to an embodiment of the present invention, wherein the indicator 10 is used for the dental instrument 100 .

[0041] Here, the dental device 100 is used to be worn in the oral cavity. This embodiment takes the dental device 100 as a shell-shaped orthodontic appliance as an example for illustration. In other embodiments, the dental device 100 may also be other dental devices that need to be worn in the oral cavity for a certain period of time, such as an orofacial muscle trainer.

[0042] The dental instrument 100 includes a dental instrument body 101 and an indicator 10 disposed on the dental instrument body 101 . The dental instrument body 101 forms a cavity S for accommodating teeth, and the dental instrument body 101 is generally made of a transparent material.

[0043] The cavity S of the dental appliance 100 for accommodating teeth has a geometry for repositioning the patient's teeth from a first layout to a second layout. For example, the geometry of the cavity S of the dental appliance 100 may be determined based on the second layout of the patient's teeth, or the geometry of the cavity S of the dental appliance 100 may substantially match the second layout of the patient's teeth.

[0044] In this embodiment, the indicator 10 may be an independently produced product and subsequently used in the dental instrument 100 .

[0045] The indicator 10 is disposed on a side of the dental instrument body 101 close to the tongue side, and / or the indicator 10 is disposed on a side of the dental instrument body 101 close to the labial side.

[0046] Here, the number and position of the indicators 10 are not limited and can be determined according to actual conditions, as long as the indicators 10 can contact the oral environment.

[0047] The indicator 10 can be fixed to the dental instrument body 101 by spraying, fixing or bonding. For example, the indicator 10 can be fixed to the dental instrument body 101 by using a glue.

[0048] The shape of the indicator 10 can be a cylinder, a cone, a rotating body, a cross-section body or other regular or irregular shapes, which can be determined according to actual conditions.

[0049] In this embodiment, the indicator 10 includes an indicator layer 11 having a controlled release preparation, and the indicator layer 11 reacts under the action of an agent in the oral cavity.

[0050] Here, the agent in the oral cavity is a mutagenic factor that can control the reaction of the indicator layer 11. The agent is, for example, saliva in the oral cavity, and specifically can be the temperature, pH value, moisture, enzyme or protein in the saliva environment.

[0051] “The indicator layer 11 having a controlled-release agent” means that the controlled-release agent is a part of the indicator layer 11 , and the controlled-release agent controls the reaction rate of the indicator layer 11 by generating physical and chemical reactions under the action of an agent in the oral cavity.

[0052] In the prior art, the wearing time of the indicator 10 is generally determined based on the current state of the indicator layer 11 after it reacts. When the reaction rate of the indicator layer 11 is not controlled, the actual wearing time required for the indicator layer 11 to reach a certain state is inaccurate. That is, the actual reaction rate of the indicator layer 11 is too fast or too slow compared to the expected reaction rate, which will cause the actual wearing time to not match the expected wearing time, thereby causing the wearing time indicated by the indicator 10 to be inaccurate and the indication effect of the indicator 10 to be poor.

[0053] In this embodiment, the reaction rate of the indicator layer 11 can be controlled by means of a controlled-release preparation, which can greatly improve the accuracy of the wearing time indicated by the indicator 10 , thereby improving the indicating effect of the indicator 10 .

[0054] In this embodiment, the indicator layer 11 displays a pattern under the action of an agent in the oral cavity.

[0055] That is to say, “the indicator layer 11 reacts under the action of the agent in the oral cavity” specifically means that the indicator layer 11 displays a pattern under the action of the agent in the oral cavity, and the controlled release preparation can be used to control the rate at which the indicator layer 11 displays the pattern.

[0056] The indicator layer 11 displays a pattern through changes in volume, shape, color, pattern or form.

[0057] That is to say, "the indicator layer 11 displays a pattern" means that the state of the indicator layer 11 changes, for example, the volume, shape, color, pattern or form of the indicator layer 11 changes, and these changes can be intuitively observed. Different degrees of change can be used to characterize different wearing time of the indicator 10. The controlled release preparation can be used to control the rate of state change of the indicator layer 11. For example, the controlled release preparation is used to control the rate of volume change of the indicator layer 11.

[0058] The state change of the indicator layer 11 includes: the indicator layer 11 gradually dissolves or expands so that the volume of the indicator layer 11 changes, or, as the wearing time increases, the shape, color, pattern, etc. of the indicator layer 11 changes, or as the wearing time increases, the indicator layer 11 undergoes a morphological change, such as changing from solid to liquid.

[0059] It should be noted that the state change of the indicator layer 11 is not limited to the above description, and the judgment of the state change of the indicator layer 11 can be qualitative judgment or quantitative judgment.

[0060] Among them, qualitative judgment, for example, the indicator layer 11 or a part of the indicator layer 11 changes from presence to absence, from large to small, from solid to liquid, from green to blue, etc.; quantitative judgment, for example, a quantitative mark coordinated with the indicator layer 11 is also provided, and compliance is judged by the indication of the quantitative mark, making the result more accurate.

[0061] For example, the indicator layer 11 reacts to generate a change area, and the indicator 10 further includes a scale area, which can be used as a quantitative mark to indicate the position information of the change area, so that the indicator 10 has a better indication effect.

[0062] To put it another way, the indicator layer 11 can display a pattern through changes in the indicator layer 11 itself, that is, the indicator layer 11 itself has an indicating function, or the indicator 10 also includes other structures with indicating functions, and other structures with indicating functions are used to characterize the degree of change of the indicator layer 11, and then characterize the wearing time of the indicator 10. Please refer to the subsequent description for details.

[0063] In addition, multiple states of the indicator layer 11 may change simultaneously. For example, as the wearing time increases, the volume and color of the indicator layer 11 may change simultaneously.

[0064] In this embodiment, the indicator layer 11 further includes a functional agent, and the indicator layer 11 releases the functional agent under the action of an agent in the oral cavity.

[0065] The functional preparation is a breath freshening preparation and / or a medicinal preparation.

[0066] In this embodiment, the functional agent is evenly distributed in the indicator layer 11, so that the controlled-release agent can effectively control the release rate of the functional agent.

[0067] Specifically, the controlled-release preparation of this embodiment is used to control the indicator layer 11 to maintain a constant reaction rate, that is, each part of the indicator layer 11 can be released constantly.

[0068] Here, “maintaining a constant” means that the reaction rate of the indicator layer 11 is basically maintained within a range with a small fluctuation, but does not mean that the reaction rate is always maintained at an absolute value.

[0069] In addition, taking the example of the indicator layer 11 decreasing in volume under the action of an agent in the oral cavity, the controlled-release preparation can make the volume of the indicator layer 11 decrease at a constant rate, and the functional preparation is released into the oral cavity at a constant rate, which can simultaneously improve the indication effect and specific functions of the wearing time of the indicator 10.

[0070] That is to say, the controlled-release preparation of this embodiment can achieve zero-order release of the indicator layer 11. Zero-order release means that the release rate of each part in the indicator layer 11 does not change with time and concentration, that is, the release rate remains constant during the release cycle of the indicator layer 11, and the process of the indicator layer 11 decreasing in volume and releasing the functional preparation will not be affected by other factors.

[0071] Several examples of functional preparations are described below.

[0072] In a first specific example, the functional agent is a breath freshening agent.

[0073] In the field of dentistry, many treatments need to be completed by wearing shell-shaped orthodontic appliances (i.e. invisible braces). Among them, patients wear shell-shaped orthodontic appliances for a long time, which causes abnormal saliva secretion in the mouth, changes in the microecology, and often causes bad breath problems. In daily life, having a fresh breath can not only enhance personal self-confidence, but also increase personal charm and improve social quality. In addition, when wearing shell-shaped orthodontic appliances, doctors usually do not recommend the use of foods such as chewing gum or breath fresheners, as this will affect people's social interactions and mental health.

[0074] The indicator layer 11 of the indicator 10 of this embodiment includes a breath freshening agent. When the patient wears a shell-shaped orthodontic appliance with such an indicator 10, the breath freshening agent can not only release fragrance itself to cover up the bad smell in the mouth, but the patient can also feel the fragrance. Therefore, the shell-shaped orthodontic appliance with the breath freshening agent can greatly enhance the product strength and increase the interest of the product, thereby improving the compliance of patients, especially improving the compliance of patients with KID products.

[0075] The indicator layer 11 of this embodiment releases the breath freshening agent under the action of the agent in the oral cavity, that is, the indicator 10 has the functions of breath freshening and compliance indication at the same time, which can achieve a better treatment effect.

[0076] The breath freshening preparation is at least one of plant extract ingredients, medicinal material extract ingredients, animal extract ingredients, fungus extract ingredients, etc. or artificially synthesized ingredients, such as menthol in plant extracts, artificially synthesized edible flavors, etc.

[0077] In a second specific example, the functional agent is a pharmaceutical agent.

[0078] Here, pharmaceutical preparations can effectively treat or alleviate oral diseases or other diseases, thereby solving the physiological needs of patients.

[0079] For example, the drug preparation contains fluoride or related ingredients, which can prevent dental caries; or, the drug preparation is tea polyphenols, which can inhibit bacteria; or, the drug preparation is Bingpengsan, which can treat oral ulcers; or, the drug preparation is commonly used antibiotics (such as amoxicillin, gentamicin, clarithromycin, amoxicillin, etc.), which can reduce inflammation.

[0080] Of course, the drug preparations are not limited to the above descriptions, and appropriate drug preparations can be selected according to actual needs. In this case, the indicator 10 has both pharmacological and compliance indication functions, which can achieve better treatment effects.

[0081] In this embodiment, the controlled release preparation includes a skeleton-type controlled release preparation, a membrane-controlled controlled release preparation or an osmotic pump controlled release preparation. The drug release mechanism of the controlled release preparation mainly includes dissolution, diffusion, erosion, osmotic pressure and ion exchange.

[0082] Several specific examples of controlled-release preparations are described in detail below.

[0083] In the first specific example, the controlled-release preparation is a skeleton-type controlled-release preparation, which can be specifically divided into the following four situations.

[0084] In the first case, the controlled-release preparation is a hydrophilic gel matrix tablet. At this time, the materials forming the hydrophilic gel matrix tablet can be divided into four categories: (1) natural gums such as sodium alginate, agar, tragacanth gum, xanthan gum, guar gum, etc.; (2) cellulose derivatives such as methyl cellulose (MC), hydroxyethyl cellulose (HEC), hydroxypropyl methyl cellulose (HPMC), sodium carboxymethyl cellulose (CMCNa), etc.; (3) cellulose polysaccharides such as chitin, galactose, mannan, etc.; (4) vinyl polymers and acrylic resins such as polyvinyl alcohol and polycarboxyvinyl, etc.

[0085] Here, the main material of the hydrophilic gel skeleton tablet is hydroxypropyl methylcellulose (HPMC) as an example. The commonly used hydroxypropyl methylcellulose is K4M (4000cpa / s) and K15M (15000cpa / s). Its drug release mechanism is to quickly form a gel skeleton tablet when it meets water to achieve controlled initial release. The firm viscous gel controls water diffusion and drug release. The controlled release principle is a combination of dissolution, diffusion and dissolution.

[0086] Specifically, hydroxypropyl methylcellulose plays a dual role as a drug reservoir and a controlled rapid-release drug in the tablet (ie, the indicator layer 11 ).

[0087] The drug release mechanism of the controlled-release preparation with hydroxypropyl methylcellulose is as follows: first, when the tablet is used in the oral cavity, the controlled-release preparation can quickly form a gel to control the initial release. The use of a water-soluble adhesive material can achieve a sustained release effect. The adhesive material must be hydrated on the surface of the tablet to form an initial gel protective layer. Compared with other celluloses, hydroxypropyl methylcellulose has a very fast hydration rate, which can ensure the rapid formation of this initial gel protective layer; secondly, the firm initial gel protective layer controls saliva diffusion and drug release. Once the initial gel protective layer is formed, the saliva outside the layer will continue to infiltrate the tablet, and the initial gel protective layer will gradually hydrate to complete dissolution, and a new gel protective layer will gradually hydrate and form to replace the initial gel protective layer. The new gel protective layer is firm and tight, and will still maintain the constant and slow diffusion of the drug, thereby continuously extending the constant release time of the drug.

[0088] Among them, the degree of erosion of the gel protective layer depends on the viscosity of the polymer. As the viscosity increases, the drug release slows down. This is because the gel protective layer has become stronger and stickier, forming a stronger barrier, slowing down the dissolution rate and tablet loss.

[0089] It can be seen that the drug release process of controlled-release preparations with hydroxypropyl methylcellulose is a complex process of interaction between water, polymers, skeleton materials and drugs. The release of drugs is affected by factors such as water penetration, polymer swelling, drug dissolution and diffusion, and skeleton dissolution. Hydroxypropyl methylcellulose forms a gel when it meets water. The release rate of water-soluble drugs depends on the diffusion rate of the drug through the gel layer, while the release rate of drugs with low solubility in water is determined by the gradual dissolution rate of the gel layer. Regardless of the drug release mechanism, the gel is finally completely dissolved and the drug is completely released, so the bioavailability is high.

[0090] In the second case, the controlled-release preparation is a wax skeleton tablet. At this time, the material forming the wax skeleton tablet is an insoluble but soluble wax material, such as carnauba wax, stearyl alcohol, stearic acid, polyethylene glycol, hydrogenated castor oil, polyethylene glycol monostearate, triglycerides, etc. The drug release mechanism of the wax skeleton tablet is controlled by pore diffusion and dissolution, which is a combination of diffusion and dissolution. Some drugs are wrapped in wax that does not penetrate water, and surfactants can be added to promote their release. Carnauba wax is usually used in combination with stearyl alcohol or stearic acid.

[0091] In the third case, the controlled-release preparation is an insoluble skeleton tablet. At this time, the materials forming the insoluble skeleton tablet are polyethylene, polyvinyl chloride, methacrylic acid-methyl acrylate copolymer, ethyl cellulose, etc. The drug release mechanism of the insoluble skeleton tablet is that the liquid penetrates the skeleton, dissolves the drug, and then diffuses out from the grooves of the skeleton. It is a combination of diffusion and dissolution. The response channel diffusion is the rate-limiting step. The release conforms to the Higuchi equation, and its bioavailability depends on the ratio of drug to controlled-release polymer.

[0092] In the fourth case, the controlled-release preparation is a controlled-release microcapsule. The controlled-release microcapsule controls the diffusion rate of the drug into the body fluid by selecting different encapsulation materials and controlling the thickness of the capsule, thereby achieving the purpose of sustained release and prolonged effect. The release mechanism includes dissolution, diffusion, degradation, and particle breakage.

[0093] In a second specific example, the controlled-release preparation is a membrane-controlled controlled-release preparation.

[0094] Here, membrane-controlled controlled-release preparations refer to a type of controlled-release preparations made by coating the surface of tablets, granules, and micropellets with one or more layers of coating film materials. The drug release mechanism of membrane-controlled controlled-release preparations is diffusion release, and the driving force is osmotic pressure or the dissolution and diffusion behavior of drug molecules in polymers.

[0095] The main difference between membrane-controlled controlled-release preparations and skeleton-type controlled-release preparations lies in the different controlled-release methods. Skeleton-type controlled-release preparations are formed by skeleton-type materials (for example, hydrophilic gel skeleton tablets can only form skeleton materials when they come into contact with water), while membrane-controlled controlled-release preparations are formed by preparations, tablets or pellets wrapped with a coating or coating, which can be specifically divided into the following three situations.

[0096] In the first case, the membrane-controlled controlled-release preparation is a microporous membrane controlled-release preparation, and polymers that are insoluble in the oral cavity, such as cellulose acetate, ethylene-vinyl acetate copolymer, polyacrylic acid resin, etc., are used as coating materials. A small amount of pore-forming substances, such as PEG, PVP, PVA, SDS, sugar, salt, or drugs are added as pore-forming agents to the liquid, and the controlled release principle is diffusion.

[0097] In the second case, the membrane-controlled controlled-release preparation is a membrane-controlled-release tablet. The membrane-controlled-release tablet is prepared by granulating the drug and excipients according to conventional methods, pressing them into tablets, and forming a coating. The diameter of the tablets is about 3 mm, and the controlled-release principle is diffusion.

[0098] In the third case, the membrane-controlled controlled-release preparation is a membrane-controlled-release pellet, which consists of a pellet core and a coating wrapped around the core, and its controlled-release principle is diffusion.

[0099] In a third specific example, the controlled-release preparation is an osmotic pump controlled-release preparation.

[0100] Here, the osmotic pump controlled-release preparation refers to a controlled-release tablet that uses osmotic pressure as a drug release energy source, and the drug release mechanism of the osmotic pump controlled-release preparation is osmotic pressure.

[0101] Osmotic pump controlled-release preparations usually consist of a tablet core and a semipermeable membrane. The tablet core consists of a drug preparation (such as a breath freshener), an osmotic pressure active substance, and a propellant.

[0102] Combination Figure 3The tablet core 202 is coated with a semipermeable membrane 201. Due to the osmotic pressure difference between the inside and outside of the semipermeable membrane 201, the water-soluble particles and the drug solution inside the semipermeable membrane 201 allow water to penetrate into the tablet core 202. Due to the volume limitation, the tension of the semipermeable membrane 201 causes the drug solution to be released outside the semipermeable membrane 201 through the drug release holes 2011 on the semipermeable membrane 201. As long as the drug in the semipermeable membrane 201 maintains a saturated solution state, the release rate is constant, that is, the drug can be released at a zero-order rate.

[0103] Among them, the material of the semipermeable membrane 201 can be selected from cellulose acetate, EC, etc.; the osmotic pressure active substance can be selected from different mixtures of lactose, fructose, glucose, and mannitol; the propellant can be selected from polyhydroxymethylacrylate (molecular weight 30,000 to 5 million), PVP (molecular weight 10,000 to 360,000), etc.; other additives include suspending agents, adhesives, lubricants and wetting agents.

[0104] Specifically, when the substance in the oral cavity enters the tablet core 201 through the semipermeable membrane 201 , the polymer material polyethylene oxide added to the booster layer absorbs water and swells to produce a higher swelling pressure and osmotic pressure, pushing the drug suspension in the drug-containing layer to be released from the drug release hole 2011 .

[0105] In this embodiment, the indicator layer 11 further includes a filling material and an adhesive material.

[0106] That is to say, the indicator layer 11 at this time mainly includes the breath freshening agent, the controlled release agent, the filling material and the adhesive material, and the indicator layer 11 is a tablet structure, but is not limited thereto.

[0107] Here, the main function of the filling material is to improve the material properties, and the main function of the bonding material is to use viscosity to bond the separated materials together.

[0108] In this embodiment, the indicator layer 11 further includes at least one of a lubricant, a disintegrant, an edible flavor and an edible coloring.

[0109] Among them, the role of the lubricant is to enable smooth feeding and reduce sticking during tableting, as well as reduce friction and make the tablet surface smooth and beautiful.

[0110] Lubricants include flow aids, anti-adhesive agents and lubricants (in a narrow sense), and at least one of fluid lubricants, boundary lubricants and mixed lubricants can be selected according to the type.

[0111] Specifically, the lubricant is at least one of magnesium stearate, calcium stearate, zinc stearate, microcrystalline cellulose, micropowdered silica gel, talc, polyethylene glycol, glyceryl monostearate, hydrogenated vegetable oil, sodium stearyl fumarate, sodium lauryl sulfate or magnesium lauryl sulfate.

[0112] The disintegrant can be selected from at least one of capillary action disintegrant, swelling action disintegrant, gas generation action disintegrant and enzymatic action disintegrant according to the mechanism of action. The function of the disintegrant is to enable the tablet to disintegrate rapidly into small molecule excipients.

[0113] In addition, edible flavors, edible pigments, etc. may be added to the indicator layer 11 as required.

[0114] In this embodiment, the process flow of the tablet-shaped indicator layer 11 mainly includes three parts: raw material processing, granulation and tableting, which specifically include:

[0115] Raw material processing: Select appropriate filling materials according to the requirements of the formula, and screen the particles through grinding and sieving.

[0116] Granulation: Most tablets need to be granulated before tableting, which is determined by the properties of the material. The purpose of granulation is to increase its fluidity and compressibility. The granulation methods mainly include extrusion granulation, wet mixing granulation, spray tumbling granulation, fluidized spray granulation and spray drying granulation.

[0117] Tableting: Tableting methods include direct compression or tableting, dry granulation and wet granulation. In direct compression, the powder materials after raw material processing are blended together and do not need to go through intermediate processing such as granulation process and are directly compressed.

[0118] Among them, the dry granulation method includes mixing the components, pressing the mixture into tablet preformation, dry screening or grinding into dry coarse particles, lubricating and pressing the lubricated particles; the wet granulation method includes mixing part or all of the parts of the dosage form, then adding a solution of a binding material to the powder of the mixture to achieve granulation, and then screening and drying the wet material, for example, by pan drying, using a fluidized bed dryer, a spray dryer, a high-frequency dryer, a microwave, a vacuum or an infrared dryer.

[0119] In this embodiment, the thickness of the indicator layer 11 ranges from 0.01 mm to 5 mm, but is not limited thereto.

[0120] In a specific embodiment, the breath freshener comprises menthol (0.01-0.5%), the filler material is mannitol (10-50%), the binder material is microcrystalline cellulose (45-85%), the controlled-release preparation is hydroxypropyl methylcellulose (1-20%), and the lubricant is magnesium stearate (0.5-3%), which can gradually dissolve in the saliva environment.

[0121] In this specific embodiment, the co-processed composition is a granular composition with an average particle size of about 30-800 microns, preferably 50-90 microns. Using 70° C. water, the acidic microcrystalline cellulose wet cake is added to the mannitol solution to form a mixture of microcrystalline cellulose and mannitol. The mixture is neutralized with ammonia and then spray-dried. Thereafter, it is lubricated with magnesium stearate and pressed into a tablet. The tablet is a round tablet with a thickness of 0.5 mm. The prepared tablet (i.e., the indicator layer 11) is directly adhered to the outer surface of the dental device body 101 with food glue. At this time, the tablet has the effects of both compliance indication and controlled release of the breath freshening agent.

[0122] In another specific embodiment, the breath freshening preparation comprises green tea powder flavor (0.01-0.5%), the filling material comprises isomalt (45-50%), the binding material comprises microcrystalline cellulose (45-50%), the controlled release preparation comprises hydroxypropyl methylcellulose (5-20%), and the lubricant comprises magnesium stearate (0.5-3%).

[0123] In this specific embodiment, the co-processed composition is a granular composition with an average particle size of about 20-200 microns. A rotary tablet press is used to directly compress the mixture. The tablet is a round tablet with an average diameter of 2.9-3.1 mm and an average thickness of 1.2-1.8 mm. The prepared tablet (i.e., the indicator layer 11) is directly adhered to the outer surface of the dental device body 101 with food glue. At this time, the tablet has the effects of both compliance indication and controlled release of breath freshening agent.

[0124] In this embodiment, the indicator layer 11 can be directly set on the dental instrument body 101 as the indicator 10. At this time, since the indicator layer 11 is directly included in the oral environment, the addition of the controlled release preparation can effectively control the reaction rate of the indicator layer 11 to avoid the indicator layer 11 from reacting too quickly, but this is not limited to this.

[0125] Next, the indicating process of the indicating layer 11 will be described.

[0126] With reference to the above description, certain forms of controlled-release preparations will swell under the action of substances in the oral cavity, and the swelling process can control the indicator layer 11 to display a pattern.

[0127] In a specific example, the controlled-release preparation swells under the action of the agent in the oral cavity, causing the volume of the indicator layer 11 to increase. At this time, the indicator layer 11 displays a pattern by increasing its volume, and the wearing time of the indicator 10 can be represented according to the size of the volume.

[0128] Here, combined Figure 4The indicator 10 may further include an encapsulation layer 12 encapsulating the indicator layer 11. The encapsulation layer 12 is elastic. On the one hand, the setting of the encapsulation layer 11 can prevent the indicator layer 11 from directly disintegrating and entering the oral cavity during the swelling process of the controlled-release preparation. On the other hand, the encapsulation layer 11 can expand in conjunction with the swelling process of the controlled-release preparation. The expansion process of the encapsulation layer 11 (i.e., the volume change process) is used to characterize the wearing time of the indicator 10.

[0129] In another specific example, the indicator layer 11 includes food coloring, and the indicator layer 11 displays a pattern through color change.

[0130] That is to say, when the controlled-release preparation swells under the action of the agent in the oral cavity, since the indicator layer 11 also includes edible pigment, the color displayed by the edible pigment will also change during the swelling process, and then the wearing time of the indicator 10 is simultaneously characterized by the change in the volume of the indicator layer 11 (i.e., the volume of the encapsulation layer 12) and the color.

[0131] Here, the encapsulation layer 12 is a transparent layer to facilitate observation of color changes.

[0132] Specific, combined Figure 5 The indicator layer 11 includes a first layer 111 and a second layer 112 stacked together. The first layer 111 has a first color. The controlled-release preparation swells under the action of an agent in the oral cavity and controls the first color to gradually penetrate into the second layer 112 .

[0133] Here, assuming that the first color is red and the second layer 112 is initially white, when the controlled-release preparation in the indicator layer 11 swells, the swelling process will not only increase the volume of the indicator layer 11, but also cause the red color to gradually penetrate into the white area of ​​the second layer 112. By observing the change in the volume of the encapsulation layer 12 and / or the area of ​​the red area, the current wearing time of the indicator 10 can be determined.

[0134] It should be noted that the encapsulation layer 12 can be made of a water-absorbing material, so that the substances in the oral cavity can pass through the water-absorbing material and contact the indication layer 11 .

[0135] Of course, in other embodiments, combined with Figure 6 The encapsulation layer 12 may have a through hole 121 communicating with the indication layer 11 and the oral cavity, and the agent in the oral cavity contacts the indication layer 11 through the through hole 121 .

[0136] At this time, the packaging layer 12 can be made of a waterproof material, and the through hole 121 is relatively small. During the flushing process of the dental instrument 100, the flushing water is not easy to penetrate the packaging layer 12 and enter the indicator 10, thereby avoiding factors such as flushing the dental instrument 100 affecting the accuracy of the indicator 10.

[0137] In this embodiment, the encapsulation layer 12 can be a porous polymer film, for example, a porous polymer film made of polymers such as polyurethane, silicone, polyacrylic acid, etc. The amount of the agent passing through can be adjusted by controlling the number and size of the through holes 121 of the encapsulation layer 12 (i.e., controlling the porosity of the encapsulation layer 12), thereby further accurately controlling the wearing time indicated by the indicator layer 11.

[0138] In this embodiment, the indicator 10 further includes a flow control layer 13 located between the indicator layer 11 and the oral cavity. The flow control layer 13 is used to control the rate at which the agent in the oral cavity enters the indicator layer 11 .

[0139] At this time, the amount of the agent reaching the indicating layer 11 can be controlled by the joint action of the through hole 121 of the encapsulation layer 12 and the flow control layer 13 .

[0140] The flow control layer 13 is a transparent layer, which can facilitate observation of the state change of the indicator layer 11 .

[0141] It should be understood that although this specification is described according to implementation modes, not every implementation mode contains only one independent technical solution. This description of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each implementation mode may also be appropriately combined to form other implementation modes that can be understood by those skilled in the art.

[0142] The series of detailed descriptions listed above are only specific descriptions of feasible implementation methods of the present invention. They are not intended to limit the scope of protection of the present invention. Any equivalent implementation methods or changes that do not deviate from the technical spirit of the present invention should be included in the scope of protection of the present invention.

Claims

1. An indicator with a controlled release formulation for use in dental instruments, characterized in that: The indicator comprises an indicator layer having a controlled release preparation, wherein the indicator layer reacts under the action of an agent in the oral cavity; the controlled release preparation is used to control the indicator layer to maintain a constant reaction rate, the controlled release preparation swells under the action of an agent in the oral cavity to control the indicator layer to display a pattern, the indicator layer displays the pattern by increasing its volume, the indicator layer comprises an edible pigment, and the indicator layer displays the pattern by changing its color, the indicator layer comprises a first layer and a second layer stacked together, the first layer has a first color, the controlled release preparation swells under the action of an agent in the oral cavity to control the first color to gradually penetrate into the second layer, and the indicator further comprises an encapsulation layer encapsulating the indicator layer, and the encapsulation layer has elasticity.

2. The indicator according to claim 1, characterized in that The indicator layer also includes a functional agent, and the indicator layer releases the functional agent under the action of an agent in the oral cavity.

3. The indicator according to claim 2, characterized in that: The functional agent is evenly distributed in the indicator layer.

4. The indicator according to claim 2, characterized in that: The functional preparation is a breath freshening preparation and / or a pharmaceutical preparation.

5. The indicator according to claim 1, characterized in that The indicator layer displays a pattern under the action of an agent in the oral cavity.

6. The indicator according to claim 1, characterized in that The encapsulation layer is a transparent layer.

7. The indicator according to claim 1, characterized in that The indicating layer further comprises a filling material and an adhesive material.

8. The indicator according to claim 1, characterized in that The indicator layer also includes at least one of a lubricant, a disintegrant and an edible flavor.

9. The indicator according to claim 1, characterized in that: The controlled release preparation is a skeleton-type controlled release preparation, a membrane-controlled release preparation or an osmotic pump-controlled release preparation.

10. The indicator according to claim 1, characterized in that The indicator layer is a tablet, and the thickness of the indicator layer ranges from 0.01 mm to 5 mm.

11. The indicator according to claim 1, characterized in that The indicator further comprises a packaging layer encapsulating the indicator layer, wherein the packaging layer has a through hole communicating with the indicator layer and the oral cavity.

12. The indicator according to claim 11, characterized in that The indicator further comprises a flow control layer located between the indicator layer and the oral cavity, wherein the flow control layer is used to control the rate at which the agent in the oral cavity enters the indicator layer.

13. The indicator according to claim 12, characterized in that The flow control layer is a transparent layer.

14. The indicator according to claim 1, characterized in that The indicating layer reacts to generate a change area, and the indicator further includes a scale area, and the scale area is used to indicate position information of the change area.

15. A dental device for wearing in the oral cavity, characterized in that: Comprising an indicator as claimed in any one of claims 1-14.

16. The dental apparatus according to claim 15, characterized in that The dental instrument comprises a dental instrument body and an indicator arranged on the dental instrument body, wherein the dental instrument body forms a cavity for accommodating teeth.

17. The dental apparatus according to claim 16, characterized in that The indicator is arranged on a side of the dental instrument body close to the tongue side, and / or the indicator is arranged on a side of the dental instrument body close to the labial side.

18. The dental apparatus according to claim 15, wherein: The dental instrument is a shell-shaped orthodontic appliance or an orofacial muscle trainer.

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