JP3158481B2 - Denture stabilizer - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a denture stabilizer excellent in usability and formulation stability.

[0002]

2. Description of the Related Art Denture stabilizers are classified into a contact type (cushion type) and an adhesive type depending on the mechanism of stabilizing the denture base, and the adhesive type depends on its form. It is classified into types such as paste, powder, and sheet.

[0003] Paste-type adhesive denture stabilizers are:
It is a non-aqueous paste-like preparation in which an adhesive such as a water-soluble polymer compound is dispersed in an oil-based base component such as vaseline or liquid paraffin, and the water-soluble polymer compound contains saliva in the oral cavity. It comes into contact with the exudate and swells or dissolves to generate adhesive force, thereby fixing the denture.

[0004] Vaseline used in this paste-like adhesive type denture stabilizer is a relatively high-molecular residual oil obtained by separating liquid paraffin and crystalline paraffin (paraffin wax) from a crude oil obtained by removing a naphtha fraction from a crude oil. Is a semi-solid wax that is separated and purified from water.Therefore, it is not just a mixture of liquid paraffin and solid paraffin, but a colloidal state in which the outer phase is composed of solid wax and the inner phase is composed of liquid oil. Is believed to be something. In addition, this vaseline is solid at room temperature, but it melts and softens as the temperature rises, and eventually becomes liquid.The solid-liquid change of vaseline changes its solid-liquid balance with temperature. This is a phenomenon caused by

[0005] Due to such properties of petrolatum, if petrolatum is present in the adhesive type denture stabilizer, the presence of petrolatum greatly contributes to the hardness of the paste (see FIG. 1). The solidification of the preparation proceeds rapidly due to the increase in the solid component ratio of petrolatum. For this reason,
Although denture stabilizers using petroleum jelly with high solid content are excellent in formulation stability after long-term storage, at low temperatures of about 5 ° C, the formulations become hard and can be placed on a denture base from tubes or other containers. Extrusion requires an extremely large force, and in some cases, the tube hardly comes out of the tube. Conversely, denture stabilizers using petroleum jelly with a large amount of liquid components are easy to extrude from containers in the form of a soft paste even at low temperatures,
When stored for a long period of time, liquid separation easily occurs even at room temperature due to the large amount of liquid components. When stored for a long time at a high temperature, vaseline is melted and the liquid components exude to voids in a tube-shaped container or the like. When reconstituted, the liquid component is liable to be separated into a translucent grease as a re-coagulated product, and therefore there is a disadvantage that the stability of the preparation is poor.

[0006] As described above, the conventional adhesive type denture stabilizer containing petrolatum has a trade-off relationship with liquid separation and translucent grease separation under solidification at a low temperature for a long period of storage. Was.

[0007]

The inventor of the present invention has conducted intensive studies to solve the above-mentioned conventional problems and obtain a denture stabilizer excellent in usability and formulation stability.
Jelly strength of 0.45 to 0.9 kg / cm ² ,
And the jelly strength at 25 ° C. is 0.1 to 0.18 k
When petrolatum controlled to g / cm ² is blended, surprisingly, the extrudability from tubes and other containers is good even at low temperatures and the usability is excellent, and almost no liquid separation occurs even when stored at room temperature for a long time. It does not occur, and it does not cause translucent grease separation after long-term storage at high temperature, is excellent in formulation stability, and therefore can simultaneously solve the above-mentioned problem of blending petroleum jelly with a trade-off relationship. Furthermore, when heavy liquid paraffin having a viscosity at 40 ° C. of 60 cSt (centistokes) or more is mixed with the veterin-containing denture stabilizer, the hardness of the preparation can be easily increased without deteriorating liquid separation after long-term storage. It was found that it could be controlled.

In this case, the jelly strength of petrolatum is determined by the difference between the chemical components in petrolatum and the solid-liquid content ratio at each temperature based on the difference. This solid-liquid content ratio in petrolatum can be measured, for example, by using wide-area NMR. Since a large number of components are present, only a part of the chemical components can be specified by a state-of-the-art analysis method (eg, gas chromatography-mass spectrum analysis method).

Although the jelly strength characteristics of petrolatum are generally higher at lower temperatures, the type and content of the chemical components in petrolatum differ depending on the grade, as described above. Since the state of petroleum jelly at 5 ° C., that is, the degree of liquid or solid, differs depending on the grade, the order of jelly strength at 25 ° C. does not always match the order of jelly strength at 5 ° C. do not do. Further, as described above, it is difficult to specify the chemical components of petrolatum, and it is impossible to estimate the jelly strength value at 5 ° C from the jelly strength value at 25 ° C.

[0010] That is, petroleum jelly has a place of production of crude oil and its refining
There are various grades depending on the conditions.
Vaseline used as a tooth stabilizer is a chew at low temperatures.
The above trade-offs between extrudability and liquid separation at room temperature
The clerk remained unresolved. In contrast, the present invention
Those at 5 ° C and 25 ° C, and at each temperature
Focusing on the physical property of jelly strength in degrees
Lee strength is 0.9kg / cm^Two Less than and 25 ° C
Jelly strength at 0.1kg / cm^TwoThat's all
Serine is used as a conventional vaseline-containing denture stabilizer
With superior usability and formulation stability
It has been found that a tooth stabilizer can be obtained.
Vaseline, which is used as a denture stabilizer, has a jelly strength
Measurement from the viewpoint of
There was nothing. (See Table 1 below).

Further, the adhesive type denture stabilizer can soften the paste state of the preparation as the amount of liquid paraffin increases, but the liquid paraffin is liquid at room temperature, so that the preparation at high temperature of the preparation can be softened. Although it does not contribute much to translucent grease separation, the liquid component content tends to increase and liquid separation tends to occur.However, when heavy liquid paraffin having the above viscosity is used as liquid paraffin, the stability of the preparation is reduced. They have also found that they can be kept well, and have accomplished the present invention.

Hereinafter, the present invention will be described in more detail. The denture stabilizer of the present invention is obtained by blending a vaseline having a specific range of jelly strength as an oily base component.

Here, the jelly strength is the maximum stress (kg / cm ² ) when the stress caused by structural destruction suddenly changes when the test substance is pushed at a constant speed. The larger the test substance, the harder the test substance and the stronger the structure. In the present invention, the jelly strength is a value measured by the following method.

Method for measuring jelly strength The preparation is filled in advance in a glass cup (36 × 23 mm in diameter) so that the surface is flat so that air does not enter, and the temperature is maintained at a predetermined temperature. 2. Using a rheometer equipped with a crimping plunger having a diameter of 20 mm (CR-200D manufactured by Sun Kagaku Co., Ltd.), the above preparation was used as a sample under the conditions of a motor speed of 50 mm / min and a jelly strength measurement mode. The measurement is performed, the value indicated on the rheometer is read, and the jelly strength of the preparation is calculated by the following formula.

Jelly strength (kg / cm ² ) = Rheometer indicated value (kg) /3.14 (cm ² ) * * Surface area of sample Vaseline used in the present invention is particularly limited to the place of origin of crude oil and its refining conditions. , But jelly strength at 5 ° C measured by the above method is 0.45 to 0.9 kg / cm ² , preferably 0.85 to 0.45 kg / cm ² , More preferably, 0.
7 to 0.55 kg / cm ² and a jelly strength at 25 ° C. of 0.1 to 0.18 kg / cm ² , preferably 0.11 to 0.18 kg / cm ² , more preferably 0.12 to 0.18 kg / cm ² The one that is 0.17 kg / cm ² is used. When vaseline with a jelly strength of more than 0.9 kg / cm ² at 5 ° C. is used, extrusion from a container such as a tube at a low temperature is hard, and even when a very strong force is applied to a fingertip, only about 1 cm of the preparation comes out from the container. The usability at low temperature is not improved, and the jelly strength at 25 ° C. is 0.1 kg
If it is less than / cm ² , the liquid component ratio is large, so that liquid separation under long-term storage and translucent grease separation after long-term storage at high temperature are likely to occur, and the stability of the preparation is not improved.

The amount of the above petrolatum is 25% of the whole preparation.
To 45% (weight%, the same applies hereinafter), particularly preferably 30 to 40%. If the amount is less than 25%, liquid separation may easily occur. It may be difficult to maintain the dosage form, and may result in a hard extrudable preparation.

The denture stabilizer of the present invention preferably contains heavy liquid paraffin in addition to the above-mentioned petrolatum as an oily base component. By mixing heavy liquid paraffin, it is possible to prevent liquid separation from increasing. It is possible to control the hardness of the paste.

Here, the heavy liquid paraffin is 40
It is preferable to use one having a viscosity at 60 ° C. of 60 centistokes (cSt) or more, particularly 65 to 85 cSt.
When heavy liquid paraffin having a viscosity of less than 60 cSt is used, when the liquid separation occurs during long-term storage, the viscosity is low, so that the separated liquid easily flows out when the cap of a container such as a tube is opened. The amount of liquid separation may increase due to the low familiarity.

The content of the heavy liquid paraffin is preferably 5% to 30%, especially 10% to 25% of the whole preparation, and if the content is less than 5%, the paste has sufficient hardness. Control may not be possible, and if it exceeds 30%, liquid separation may easily occur.

The denture stabilizer of the present invention may contain, in addition to the above components, a water-soluble polymer, a saturated fatty acid ester, and other optional components as long as the effects of the present invention are not impaired. Here, the water-soluble polymer compound is used as an adhesive component. For example, polyethylene oxide, sodium carboxymethylcellulose (CMC-
Na), sodium polyacrylate, sodium alginate, karaya gum and the like, and these can be used alone or as a mixture of two or more. Among these, polyethylene oxide and CMC-Na are preferable,
In order to further maintain and stabilize the denture, polyethylene oxide preferably has an average molecular weight of 500,000 to 5,000,000, and CMC-Na has a degree of etherification of 0.5 to 1.3.
The 1% aqueous solution viscosity is 50-3500 centipoise (2
(5 ° C.).

[0021]

Industrial Applicability The denture stabilizer of the present invention has good extrudability from a container such as a tube even at a low temperature and is excellent in usability, and almost no liquid separation occurs even when stored at room temperature for a long time. In addition, without translucent grease separation after long-term storage at high temperature, excellent formulation stability,
In addition, control of hardness can be easily performed.

[0022]

EXAMPLES The present invention will be specifically described below with reference to examples, but the present invention is not limited to the following examples. In addition, all% in each example are weight%. Also,
Prior to the examples, the effects of the present invention will be specifically shown by experimental examples.

[Experimental Example 1] A denture stabilizer having the following formulation was prepared using petroleum jelly having various jelly strengths shown in Table 1, and was filled in a tube, followed by extrusion hardness, liquid separation and grease. The separation was evaluated by the following method. Table 1 shows the results.

Formulation of denture stabilizer Sodium carboxymethyl cellulose 35.0% Polyethylene oxide 15.0 Liquid paraffin 15.0 Vaseline Balance shown in Table 1 Preservatives Fine Colorant Fine pH adjuster 0.2 Perfume Fine The amount a total of 100.0%

(1) Method of Evaluating Extrusion Hardness After the denture stabilizer was stored at 5 ° C. for 1 day, the extrusion hardness was evaluated according to the following criteria.

Evaluation on actual use 5 points: When force is applied to the fingertip and the product is pushed out of the tube, 5 cm or more of the agent comes out. 4 points: When force is applied to the fingertip and pushed out of the tube, the agent of 3 to 5 cm comes out. 3 points: When force is applied to the fingertip and pushed out of the tube, o 3 cm or less of agent comes out. 2 points: When force is applied to the fingertip and the material is pushed out of the tube, an agent of Δ2 cm or less comes out. 1 point: When force is applied to the fingertip and the tube is pushed out of the tube, an agent of × 1 cm or less comes out.

(2) Evaluation Method of Liquid Separation The denture stabilizer was stored at 25 ° C. for 3 months, and the state of liquid separation was evaluated according to the following criteria.

Evaluation in practical use 5 points: No liquid separation. ○ 4 points: Slight separation in the preparation or in the void. ○ 3 points: There is almost uniform separation in the preparation, or there are many separations in voids. 2 points: There is remarkable separation in the preparation or in the void. X 1 point: remarkably outflow of separated liquid when extruded or when opening tube.

(3) Evaluation method of grease separation The denture stabilizer was stored at 40 ° C. for one month, and then returned to room temperature. The grease separation state was evaluated according to the following criteria.

Evaluation in practical use 3 points: There is no grease separation. ２ Two points: Grease was slightly separated in the gap. ○ 1 point: grease is uniformly separated in the gap. ×

[0031]

[Table 1]

From the results shown in Table 1, the jelly strength at 5 ° C. is 0.9 kg / cm ² or less, and the jelly strength at 25 ° C. is 0.1 kg / cm ² or more. Denture stabilizer containing 5) (product of the present invention)
It was confirmed that the product had good extruded hardness from the tube and was excellent in usability, hardly liquid separation or grease separation, and was excellent in formulation stability.

[Experimental Example 2] Various viscosities (40
C), a denture stabilizer having the following formulation was produced using liquid paraffin, and the state of liquid separation after storage at 25 ° C. for one month was evaluated according to the same criteria as described above. In addition, the viscosity value at 40 degreeC used the method described in the Japanese Pharmacopoeia, the liquid paraffin test method. Table 2 shows the results.

Formulation of denture stabilizer sodium carboxymethyl cellulose 35.0% polyethylene oxide 15.0 Liquid paraffin 15.0 No. shown in Table 1 Vaseline balance of 3 (Jelly strength 25 ° C: 0.13 kg / cm ² , 5 ° C: 0.65 kg / cm ² ) Preservatives Fine colorant Fine pH adjuster 0.2 flavor micrometer 100.0 %

[0035]

[Table 2]

From the results in Table 2, it can be seen that when heavy liquid paraffin (Nos. 3 and 4) having a viscosity of 40 cSt or more at 40 ° C. was added to the denture stabilizer of the present invention as a liquid paraffin, the preparation was prepared without deteriorating the liquid separation. It has been found that it is possible to control the hardness.

[Example 1] Sodium carboxymethyl cellulose 37% Polyethylene oxide 12 Propyl parahydroxybenzoate 0.05 Sodium dihydrogen phosphate 0.2 Fragrance 0.01 Iron sesquioxide 0.01 Heavy liquid paraffin ( 1) (Viscosity at 40 ° C .: 67.5 cSt) Balance Vaseline (1) 37.0 (Jelly strength 25 ° C .: 0.14 kg / cm ² , 5 ° C .: 0.85 kg / cm ² ) Total 100.0%

Example 2 Sodium carboxymethylcellulose 32% Polyethylene oxide 15 Propyl parahydroxybenzoate 0.05 Sodium dihydrogen phosphate 0.2 Fragrance 0.01 Iron sesquioxide 0.01 Heavy liquid paraffin ( 2) (40 ° C. viscosity: 75.0 cSt) Balance Vaseline (2) 35.0 (Jelly strength 25 ° C .: 0.13 kg / cm ² , 5 ° C .: 0.65 kg / cm ² ) Total 100.0%

Example 3 Karaya Gum 45% Propyl parahydroxybenzoate 0.05 Sodium dihydrogen phosphate 0.2 Flavor 0.01 Iron sesquioxide 0.01 Heavy liquid paraffin (1) (viscosity at 40 ° C .: 67) 0.5 cSt) Balance Vaseline (3) 30.0 (Jelly strength 25 ° C: 0.16 kg / cm ² , 5 ° C: 0.60 kg / cm ² ) Total 100.0%

[Brief description of the drawings]

FIG. 1: Jelly of adhesive denture stabilizer at 5 ° C.
It is a graph which shows the correlation between intensity | strength and the jelly intensity | strength of petrolatum blended in this preparation.

──────────────────────────────────────────────────続 き Continuation of the front page (56) References JP-A-60-253440 (JP, A) JP-A-1-180807 (JP, A) JP-A-51-94693 (JP, A) 10549 (JP, B1) (58) Fields investigated (Int. Cl. ⁷ , DB name) A61C 13/225-13/32 A61K 6/00 A61K 47/46

Claims (2)

(57) [Claims] 1. Jelly strength at 5.degree.
0.9 kg / cm ^2, and, denture adhesive, characterized in that by blending a petroleum jelly strength is 0.1~0.18kg / cm ² at 25 ° C.. 2. The denture stabilizer according to claim 1, further comprising heavy liquid paraffin having a viscosity at 40 ° C. of 60 centistokes or more.