WO2009157377A1

WO2009157377A1 - Buccal anaesthetic

Info

Publication number: WO2009157377A1
Application number: PCT/JP2009/061177
Authority: WO
Inventors: 一也中嶋; 慶太楠本
Original assignee: 田中和美
Priority date: 2008-06-24
Filing date: 2009-06-19
Publication date: 2009-12-30
Also published as: JPWO2009157377A1

Abstract

Disclosed is a buccal anaesthetic, which is a liquid buccal anaesthetic used for dental examination or dental treatment, containing an anaesthetic authorized under the Pharmaceutical Affairs Law. A given container is filled with a quantity of aforementioned liquid buccal anaesthetic used for a single dental examination or dental treatment, in a state in which outside air is excluded, and when buccal anaesthesia is carried out, the aforementioned liquid buccal anaesthetic is administered to the patient by unsealing the aforementioned container, after which this buccal anaesthetic is used as a gargle.

Description

Oral anesthetic

The present invention relates to an intraoral anesthetic used for professional tooth cleaning, calculus removal, dental examination, dental treatment, oral surgery, or otolaryngology treatment.

Tooth surface cleaning by professionals (professional mechanical tooth cleaning, hereinafter referred to as “PMTC”), dental removal (hereinafter referred to as “scaling”). ), Patients feel pain during dental examination, dental treatment, oral surgery, or otolaryngology procedures. Since the oral cavity is a sensitive place, the patient suffers a great mental burden even with slight pain as well as severe pain. Therefore, an anesthetic is administered to remove or alleviate the pain.
For example, during tooth extraction or large-scale cutting, since severe pain occurs, a predetermined anesthetic is administered to the gums by injection or the like.
On the other hand, P.I. M.M. T.A. C, scaling, periodontal disease examination, minor cutting, plaque removal and other dental examinations or treatments do not cause severe pain such as tooth extraction or large-scale cutting, but patients feel uncomfortable Pain occurs.

Under such circumstances, advanced dentists and doctors M.M. T.A. Prior to C, scaling, dental examination, dental treatment, oral surgery, or otolaryngology treatment, a coated anesthetic, spray-type anesthetic, or jelly-like anesthetic is administered to the patient for the dental examination, etc. The resulting pain is removed (for example, see Patent Document 1).

JP 2006-16067 A

However, according to the study of the present inventor, the following problems have been clarified.
First, the subject that the dose to a patient was not quantified by the application type | formula anesthesia became clear.
As a result, if the dose is insufficient, the effect of anesthesia is insufficient and the patient is uncomfortable. On the other hand, if the dose is excessive, it may adversely affect the health of the patient even though it is an external anesthetic.
Next, if it is a jelly-like anesthetic, it is easy to quantify the dosage to a patient. However, jelly-like anesthetics may not reach the location where anesthesia is desired due to the dosage form. For example, it is not effective in areas such as gaps between teeth and periodontal pockets. However, exactly these points are M.M. T.A. It is often the subject of C, scaling, dental examination, dental treatment or oral surgery.
Furthermore, these application-type anesthetics, spray-type anesthetics, and jelly-like anesthetics require a time of about 5 minutes from the time they are administered to a patient until the anesthetic effect is exerted, which impedes rapid treatment. Yes.

In the present invention, in consideration of the above circumstances, P.I. M.M. T.A. C, Scaling, Periodontal disease inspection, Minor cutting, Dental removal such as plaque removal, Dental treatment, Oral surgery, or Otolaryngology procedure, safely remove the discomfort experienced by the patient and promptly An object of the present invention is to provide an oral anesthetic agent that enables treatment.

In order to solve the above-mentioned problems, the present inventor has conducted intensive research.
P. M, T.M. C, Scaling, Periodontal disease examination, Minor cutting, Dental removal such as plaque removal, Dental treatment, Oral surgery, Oral anaesthesia that can safely remove the discomfort experienced by patients I came up with a mouthwash as a dosage form of the agent. If it is the said dosage form, it will osmose | permeate easily also to areas, such as the space | gap between teeth, a periodontal pocket, etc., and the effect of an anesthetic can be exhibited in about 10 second short time.

Here, the present inventor further tackled the contradictory problem of effectiveness and safety of anesthesia, and examined a strict quantitative administration method of an anesthetic agent. Then, the present invention has been completed by conceiving a configuration in which a predetermined container is filled with only an amount of the oral anesthetic used in one dental treatment or the like.

That is, the first invention for solving the above-described problem is
A liquid oral anesthetic used during professional tooth cleaning, tartar removal, dental examination, dental treatment, oral surgery, or otolaryngology procedures,
Contains anesthetics approved by the Pharmaceutical Affairs Law,
The amount of the liquid oral anesthetic used in the single dental examination or dental treatment is filled in a predetermined container in a state of being blocked from the outside air,
When performing oral anesthesia, the container is opened and the liquid oral anesthetic agent is administered to a patient, and then the oral anesthetic agent is treated in the form of gargle. Anesthetic.

The second invention is
In addition to the anesthetic that has been approved by the Pharmaceutical Affairs Law, a bactericide that has been approved by the Pharmaceutical Affairs Law is contained.

The third invention is
The intraoral anesthetic according to the first or second invention, wherein lidocaine hydrochloride is contained as an anesthetic that has been approved by the Pharmaceutical Affairs Law.

The fourth invention is:
The oral anesthetic agent according to the second or third invention, characterized in that it contains chlorohexidine as a fungicide that has been approved by the Pharmaceutical Affairs Law.

The fifth invention is:
The oral anesthetic according to any one of the first to fourth inventions, wherein a plastic portion container is used as the container.

P. M.M. T.A. C, scaling, dental examination, dental treatment, oral surgery, or otolaryngology treatment is performed by a patient who gargles with the oral anesthetic according to the present invention, so that the patient's oral cavity is sufficient, and Since it is safely and rapidly anesthetized, P.P. M.M. T.A. C, scaling, dental examination, dental treatment, oral surgery, or otolaryngology procedures can be performed.

Hereinafter, embodiments of the present invention will be described in detail.
1. Anesthetics The anesthetics used for the oral anesthetic according to the present invention may be those that have already been approved by the pharmaceutical law (the Pharmaceutical Affairs Law in Japan) in the country where the oral anesthetic is used. Examples thereof include lidocaine, epinephrine, mepivacaine hydrochloride, ethyl paraaminobenzoate, oxybuprocaine, tetracaine, procaine, diethylaminoethyl parabutylaminobenzoate, or a pharmaceutically acceptable salt thereof, or a mixture thereof. . Preferably, lidocaine hydrochloride, epinephrine, and mepivacaine hydrochloride are used.
The optimum concentration of the anesthetic varies depending on the drug type, but 2% to 3% is preferable for lidocaine hydrochloride and mepivacaine hydrochloride.
These anesthetics act on C-FIBER at the nerve endings and have the effect of instantly relieving pain such as the mild mucous membranes in the oral cavity that many patients feel uncomfortable. The immediate alleviation of pain in the mucous membrane and the like has made it possible to reduce the unpleasant experience that patients feel during dental treatment and the uncomfortable feeling during injection. As a result, dentists can now perform treatment more safely.

2. Bactericidal agent / anti-inflammatory agent It is preferable to add a bactericidal agent or an anti-inflammatory agent to the oral anesthetic agent according to the present invention for the purpose of bactericidal / anti-inflammatory in the oral cavity. It can be expected to have an effect on periodontal disease and its prevention by using in combination with the cleaning aid described later. Examples of the disinfectant and anti-inflammatory agent include chlorohexidine, azulene salt, tranexamic acid salt, carnosine salt, cetylpyridinium chloride, triclosan, methylene blue, povidone iodine, benzalkonium chloride, and ethanol. Furthermore, addition of a fluorine mouthwash is also preferable.

3. pH adjuster In order for the anesthetic agent to act effectively, it is preferable to adjust the preparation to a predetermined pH when using the oral anesthetic agent. For example, it is preferable to adjust to pH 4 ± 1 for lidocaine hydrochloride and pH 5.5 ± 1 for mepivacaine hydrochloride. Therefore, it is preferable to add a pH adjuster. Examples of the pH adjuster include acids such as hydrochloric acid, dilute hydrochloric acid, boric acid, phosphoric acid and salts thereof, citric acid, succinic acid, malic acid, tartaric acid, lactic acid, ascorbic acid, fumaric acid, maleic acid, gluconic acid, Examples thereof include organic acids such as glucuronic acid and acetic acid and salts thereof, and bases such as potassium hydroxide, calcium hydroxide, sodium hydroxide, magnesium hydroxide, sodium carbonate and sodium hydrogen carbonate. It may be a mixture of the acid and base. Preferably, the mixture of the organic acid of a citric acid and malic acid, sodium hydroxide, and sodium hydrogencarbonate is mentioned.

4). Thickener It is also preferable to add a thickener so that the oral anesthetic agent according to the present invention effectively stays in the oral cavity. Examples of the thickener include glycerin, propylene glycol, hydroxyethyl cellulose, hydroxyethyl methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, sodium alginate, and gelatin.

5). Other additives In order to improve the feeling of use of the oral anesthetic according to the present invention, addition of a bad breath inhibitor, a refreshing agent, a disinfectant, a fragrance, a solubilizer, a cleaning aid, a colorant, etc. is also a preferred configuration. is there.
For example, sweeteners such as aspartame, stevia, thaumatin, erythritol, sorbitol, xylitol, and saccharin sodium can be blended. In addition, for example, fragrances such as lemon, orange, grapefruit, pine, banana, chocolate, yogurt, vanilla, menthol and the like can be blended.
In addition, for example, various herbs, cinnamon bark, licorice, clove and other herbal medicines can be blended. Further, for example, various vitamins such as vitamin C and vitamin E can be blended.
Further, a solubilizer such as polyoxyethylene hydrogenated castor oil and a cleaning aid such as cocoyl arginine ethyl PCA can be blended.

6). Oral anesthetic agent dosage form according to the present invention (1) The oral anesthetic agent dosage form according to the present invention is preferably an aqueous solution dosage form. This is because the oral anesthetic agent can be opened at the side of the patient and immediately administered to the patient to gargle. Then, the present inventors can administer the oral anesthetic agent to the patient in the form of gargle, so that the oral anesthetic agent according to the present invention is a conventional application-type anesthetic, spray-type anesthetic, jelly Compared to a state-of-the-art anesthetic, it is considered to exhibit an anesthetic effect quickly.

To gargle, close the mouth with liquid, quickly swell and return to the cheeks, and quickly rinse, open the mouth with liquid, so-called `` buzz gargle '' and exhale upwards There is a so-called "rattle gargle". Whatever the gargle, the liquid which is an oral anesthetic according to the present invention becomes a turbulent state in the oral cavity. For example, a sufficient amount of the drug can be quickly applied to a narrow part including a periodontal pocket and a tooth. To penetrate. Rapid penetration of a sufficient amount of drug into the narrow part of the oral cavity and the rapid supply of anesthetic by the constant supply of fresh drug to the oral part other than the narrow part is achieved. It is thought to be a thing.

Specifically, in the case of the conventional application-type anesthetic, spray-type anesthetic, and jelly-like anesthetic, it took 5 minutes or more until a sufficient anesthetic effect was obtained after administration to the patient. On the other hand, in the case of the oral anesthetic according to the present invention, a sufficient anesthetic effect was immediately obtained in about 10 seconds after administration to the patient.
Then, the oral anesthetic agent is administered to the patient under the management of the doctor, and after gargle for about 10 seconds, the patient immediately exhales from the oral cavity according to the doctor's instruction, and is quickly discharged.

(2) The intraoral anesthetic agent according to the present invention is prepared by sealing and storing an amount of the oral anesthetic agent used once per patient as one pack. By taking the said form, it aims at avoiding the excess and deficiency of the usage-amount of an oral anesthetic agent. Furthermore, it is intended to give the patient a sense of security and cleanliness by taking the form and using the form diluted with an appropriate amount of water on the side of the patient.
Therefore, the container is preferably a disposable sealed container. Specifically, a portion type container, a bottle type container, an ampoule, etc. are mentioned. FIG. 1 is a perspective view of an example of a portion type container, and FIG. 2 is a perspective view of an example of a bottle type container with a lid.

The portion type container shown in FIG. 1 has a plastic lid (2) bonded to the upper part of a plastic cup-shaped container (1). The oral anesthetic agent according to the present invention filled in the container part (1) is blocked from the outside air by the lid part (2). What is necessary is just to peel a cover part (2) from a container part (1) at the time of use of the oral cavity anesthetic which concerns on this invention.
You may give a scale (9) to a container part (1) if desired. The interval of the scale (9) is preferably 25%, 50%, 75% of the total content.

In the bottle type container shown in FIG. 2, the upper part of the plastic bottle container (3) and the plastic lid (4) are in close contact with each other by screws. The oral anesthetic agent according to the present invention filled in the container part (3) is blocked from the outside air by the lid part (4). When using the oral anesthetic according to the present invention, the lid (4) may be removed from the container (3).
You may give a scale (9) to a container part (3) if desired. The interval of the scale (9) is preferably 25%, 50%, 75% of the total content.

The ampule type container shown in FIG. 3 is a glass ampule container (5) filled with the oral anesthetic agent according to the present invention. The oral anesthetic according to the present invention filled in the glass ampoule container (5) is blocked from the outside air. When using the oral anesthetic according to the present invention, the ampoule container head may be cut off and removed.
You may give a scale (9) to a container part (5) if desired. The interval of the scale (9) is preferably 25%, 50%, 75% of the total content.

The portion type container shown in FIG. 4 has a plastic lid portion (8) bonded to the upper part of two or more plastic cup-shaped container portions (6) and (7). The oral anesthetics according to the present invention filled in two or more container parts (6) and (7) are blocked from the outside air while being separated from each other by the lid part (8). When using the oral anesthetic according to the present invention, the lid (8) may be peeled off from the container (6) (7).
The container is suitable for the case where it is desired to keep each component separated until just before administration to a patient from the viewpoint of mixing stability, compatibility and the like of components contained in the oral anesthetic agent.
You may give a scale (9) to a container part (6) (7) if desired. The interval of the scale (9) is preferably 25%, 50%, 75% of the total content.

Considering the ease of gargle of the patient, the ease of storage of the container filled with the oral anesthetic, operability, etc., it is considered that the amount of oral anesthetic agent at one time is preferably 10 to 15 ml, more preferably 12 to 13 ml. It is done. Furthermore, for children, it is convenient to use the same oral anesthetic agent as that for adults, and to reduce the amount of oral anesthetic agent to ½ amount for adults, for example. Of course, the amount of the oral anesthetic agent can be the same as that for adults, and the concentration of the oral anesthetic agent can be halved for adults, for example. From the viewpoint of adjusting the concentration of the oral anesthetic agent, as described above, it is also preferable to pre-scale the container. For example, if a scale is provided at positions corresponding to 25%, 50%, and 75% of the total amount of the oral anesthetic agent, the dose to the patient can be easily adjusted.

7). P. of the present invention. M.M. T.A. Application to C, scaling, dental treatment, oral surgery, or otolaryngology treatment The present invention does not cause severe pain such as tooth extraction or large-scale cutting, but causes pain that makes the patient feel uncomfortable P. M.M. T.A. C, Scaling, Periodontal disease examination, Minor cutting, Dental removal or dental treatment such as plaque removal, etc., It is most suitable for oral surgery or otolaryngology treatment.
These P.I. M.M. T.A. In the case of C, scaling, dental treatment, etc., a unique tingling pain occurs, making the patient feel uncomfortable. Furthermore, in recent years, some dental lasers having various wavelengths for soft and hard tissues in the oral cavity have been covered by insurance in the dental field. Along with this, it is expected that dental laser treatment will be frequently used in the future. The present invention is optimal as a means for removing patient discomfort during the laser treatment.
Specifically, the oral anesthetic agent according to the present invention is included in the patient's mouth immediately before the above-described treatment, and the patient side and the dentist / doctor side are comfortable and quick by garbling for about 10 seconds. You can share the treatment time.

Example 1
As an intraoral anesthetic according to Example 1, Leptospan S (containing 2% lidocaine hydrochloride and 0.00125% epinephrine) manufactured by Septdon was prepared.
The oral anesthetic agent 12 ml shown in FIG. 1 is filled and sealed in a plastic portion type container (internal volume 12 ml), the lid of the portion type container is sealed, and the oral cavity according to Example 1 is sealed. An internal anesthetic was used.

The dentist opened the manufactured oral anesthetic container according to Example 1 beside the patient. Then, the dentist administered the oral anesthetic agent to the patient, gargled for about 10 seconds, instructed to discharge, and immediately discharged from the oral cavity.

After the gargle, M.M. T.A. C, Scaling, Periodontal Examination, Dental Examination and Dental Treatment of Plaque Removal. According to interviews with the patient, the effect of anesthesia began immediately after gargle. The intensity of anesthesia was not so strong. M.M. T.A. C, scaling, periodontal disease test, the tingling sensation associated with the removal of plaque and the impression that mild pain was not felt.

Next, an interview survey was conducted with dentists who treated dental treatment. Then, since the oral anesthetic is sealed and stored, it is safe in terms of storage and management, and the amount of oral anesthetic that can be used once per patient is in one pack. The point that it was possible to avoid the excess and deficiency of was surely excellent.

Eventually, an oral anesthetic is prepared right next to the patient, and appropriate oral anesthesia is treated for the patient simply by gargleing the oral anesthetic. As a result, both the patient and the dentist were relieved and were able to perform dental examination and treatment in a relaxed state.

In the above, referring to the examples, P.I. M.M. T.A. The oral anesthetic agent according to the present invention has been described by taking dental examination or dental treatment with relatively light pain such as C, scaling, periodontal disease examination, minor cutting, and plaque removal as an example. However, the intraoral anesthetic according to the present invention can also be used as an anesthetic for oral surgery and otolaryngology treatment. Furthermore, it can also be used as a preliminary anesthetic agent that relieves the pain of anesthesia injection performed prior to treatment such as extraction with strong pain.

It is an external appearance of the container of the intraoral anesthetic concerning this invention. It is an external appearance of the container from which the intraoral anesthetic concerning this invention differs. It is an external appearance of the container from which the intraoral anesthetic concerning this invention differs. It is an external appearance of the container from which the intraoral anesthetic concerning this invention differs.

(1) Container part (2) Lid part (3) Container part (4) Lid part
(5) Container part (6) Container part (7) Container part (8) Lid part
(9) Scale

Claims

A liquid oral anesthetic used during professional tooth cleaning, tartar removal, dental examination, dental treatment, oral surgery, or otolaryngology procedures,
Contains anesthetics approved by the Pharmaceutical Affairs Law,
The amount of the liquid oral anesthetic used in the single dental examination or dental treatment is filled in a predetermined container in a state of being blocked from the outside air,
When performing oral anesthesia, the container is opened and the liquid oral anesthetic agent is administered to a patient, and then the oral anesthetic agent is treated in the form of gargle. Anesthetic.
The oral anesthetic according to claim 1, further comprising a fungicide approved by the Pharmaceutical Affairs Law in addition to the anesthetic approved by the Pharmaceutical Affairs Law. *
The oral anesthetic according to claim 1 or 2, which contains lidocaine hydrochloride as an anesthetic that has been approved by the Pharmaceutical Affairs Law. *
The oral anesthetic according to claim 2 or 3, which contains chlorohexidine as a bactericide that has been approved by the Pharmaceutical Affairs Law. *
The oral anesthetic according to any one of claims 1 to 4, wherein a plastic portion container is used as the container. *