JPS61149128A - Transparent viscous composition for ultrasonic diagnosis - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

Detailed Description of the Invention (Measures of the Invention) The present invention aims to improve the propagation of ultrasonic energy when using an ultrasonic diagnostic device. The present invention relates to a transparent viscous composition for ultrasonic diagnosis that is applied and interposed between a probe (abbreviated as a probe).

(Prior art) Conventional ultrasonic diagnostic compositions tend to flow when they are in contact with the skin for a long time due to skin temperature, or salting out occurs in the composition due to sweating, causing the composition to become liquid. As a result, the composition is difficult to stay in place between the probe and the skin, and a gap is created with an air layer intervening, resulting in crystallization, which often impairs the propagation of ultrasound energy.

In addition, although highly viscous gel-like materials have good adhesion to the skin and probe, it is difficult to remove air bubbles that are mixed in during manufacturing or application, and air layers (bubbles) may also be present. This inevitably results in poor propagation of ultrasonic energy, resulting in drawbacks such as making it impossible to obtain accurate diagnostic information with good reproducibility.

Furthermore, the highly viscous gel-like material is extremely sticky;
It is inconvenient to use, causes discomfort to the patient, and is difficult to remove after use.

(Objective of the Invention) The present invention improves all the above-mentioned drawbacks, and aims to fix the probe and the skin, have appropriate adhesion, and provide ultrasonic energy to the skin. It is stable against body temperature and perspiration, retains moisture for a long time, prevents the formation of air spaces, does not irritate the skin, and is easy to remove after use. An object of the present invention is to provide a transparent viscous composition for ultrasonic diagnosis that has excellent storage stability.

It is characterized by being made by blending xyvinyl polymer wood, hydroxyethyl cellulose, disodium phosphate, monopotassium phosphate, polyhydric alcohol, and water.

(Description of specific structure of the invention) The carboxyvinyl polymer salt used in the present invention is a free acid type carboxyvinyl polymer (for example, Carbopol 940 manufactured by Gudrich Co., Ltd. in the United States), caustic soda, caustic potash, and an alkanol. It is a neutralization salt with basic substances such as main carbon. The preferred basic substance is caustic soda or caustic potash. The pH value of the aqueous solution of the carboxyvinyl polymer salt is 6-8.

The amount of carboxyvinyl polymer salt blended is 0.4 to 1.2% by weight, preferably 0.6% by weight based on the total amount of the composition.
When the amount is less than 90.4% by weight, which is ~1.0% by weight, it becomes a liquid (does not form the desired viscous material), flows and is difficult to maintain between the skin and the probe, resulting in an air layer. is likely to intervene. If the weight exceeds 1.2, the viscosity becomes high, making it difficult to adhere tightly to any part of the human body, such as a flat or curved surface, and also extremely difficult to remove after use.

Hydroxyethyl cellulose is, for example, Cellosize WP-4400M manufactured by Union Carbide, USA.

Any material such as A3000F manufactured by Fuji Chemical Co., Ltd. may be used, and one having a viscosity of 4000 to 6000 CPS (Brookfield rotational viscometer, measurement temperature 25°C, 2 weight - aqueous solution) is suitable.

Hydroxyethyl cellulose is blended in order to improve the unique gel-like (pudding-like) viscosity exhibited by the above-mentioned carboxyvinyl polymer to meet the purpose of the present invention, and the composition of the present invention maintains transparency. When applied between the probe and the skin, it not only has appropriate extensibility (fluidity), but also has the effect of interposing between the probe and the skin and maintaining continuous adhesion. be. Furthermore, hydroxyethyl cellulose is non-ionic, extremely stable against salts, and has excellent acid resistance and alkali resistance. Unlike other carboxymethyl cellulose and sodium alginate, it does not cause kelization (pudding-like) and has the property of being resistant to spoilage.

The blending amount of hydroxyethyl cellulose is 0.03 to 0.
3% by weight, preferably 0.05-0.6wt/h.

be. When K is less than 0.03 weight Jl, the above effect cannot be exhibited, and when it is more than 0.3 weight, the transparency of the composition decreases and the viscosity becomes high, making it difficult to obtain appropriate extensibility (elongation). Can not.

The blending ratio of disodium phosphate and monopotassium phosphate is 1:02-6, O, and the total blending amount of both is 0.2-2.6.
% by weight (preferably 0.4 to 2.0 weight fk). When the amount is less than the above minimum limit, the pH buffering effect is reduced and the storage stability of the composition is likely to deteriorate. Moreover, if the amount exceeds the maximum limit, salting out phenomenon occurs, causing opacity and water separation, and storage stability is likely to deteriorate.

Polyhydric alcohols include glycerin and diglycerin.

Propylene glycol, dipropylene glycol.

It may be at least one selected from the group consisting of 1,3-butylene glycol and polyethylene glycol, and the blending amount thereof is 10 to 80% by weight based on the total amount of the composition. The type of polyhydric alcohol is not particularly limited, but it is particularly preferable that chrycerin and propylene glycol are blended in a ratio of 0.6 to 1.6 to 1, with a total blending amount of 18 to 26% by weight. Ru. When the amount of polyhydric alcohol is less than 10% by weight, the composition tends to dry, the adhesion between the probe and the skin is reduced, and the propagation of ultrasound energy may be attenuated. If this happens, the transparency will decrease and the storage stability will also deteriorate.

The amount of water blended is 60 to 85% by weight, preferably 66 to 80% by weight based on the total amount of the composition, and even if it is less than 60% by weight or more than 80% by weight, the object of the present invention can be achieved. It is difficult to obtain compositions that The viscosity of the composition is preferably adjusted to 20,000 to 260,000 CPS (measured by the method described in Examples).

The present invention will be explained below with reference to Examples.

(1) Appearance, (2) Storage stability, (3) described in Examples
viscosity.

(4) Practical property tests [■Drying resistance (water retention) and perspiration resistance, ■Adhesion, ■Attenuation of ultrasonic energy propagation.

■Skin irritation] was investigated using the following method.

(1) External appearance A sample whose temperature was 10 to 46°C and was transparent was defined as transparent.

(2) Storage stability After storing samples for 8 months in a constant temperature room where the temperature is repeatedly changed from 110°C to 45°C every 2 weeks, those with a transparent appearance and no separation of water are considered stable. was made unstable.

(3) Viscosity The temperature of the sample was set to 80°C, and it was measured with a Brookfield viscometer (Bismetron US-Al type manufactured by Precision Engineering Research Institute, rotor No. 4, rotation speed 8r11p11m), and the unit was centiboise (CPS). Indicated.

(4) Practical characteristics IC for each sample A practical characteristics test for ultrasound diagnosis was conducted on 20 test subjects by interposing the sample between the probe and the skin and applying KX in close contact for 15 minutes. We investigated the items.

■Drying resistance (water retention) and perspiration resistance During the measurement period, a part of the sample flowed or dried to form an air space, which was expressed as a number of nine people.

■Adhesiveness It is shown in the number of people in whom an air layer was created due to flow of the intervening sample when the contact surface between the probe and the skin was inclined (80@).

■ Attenuation of ultrasonic energy propagation If air bubbles are mixed into the sample, or if the sample flows or dries during the measurement period, changes may occur such as a decrease in the clarity of the image displayed on the TV. It is shown in the number of people born.

■ Skin irritation If you feel irritation on your skin during the measurement, or if you have red spots or edema on your skin after the measurement is completed and the sample is removed, etc. Examples 1 to 8. Comparative Examples 1 to 8 (1) Composition Synthesis However, the amount of caustic soda is PL-1llp of the composition.
AQ, υ・-7, adjusted in advance to be OK, with nine quantities,
It is contained in the blended amount of Carbopol 940 and NaoH.

(2) Li production method After dispersing Carbopol 940 in a mixture of propylene glycol and glycerin in the remaining amount of water, pour in an aqueous solution of Cellosize WP-4400M (preliminarily wetted) and mix with stirring.Next An aqueous solution of caustic soda is poured into the solution, and the aqueous solution of caustic soda is uniformly stirred and mixed to produce a neutralized salt which is neutralized with CARPOBOL-940T-caustic soda.Subsequently, disodium phosphate, potassium phosphate, methyl paraben and Blue 1 are added. Prepare by injecting each aqueous solution and stirring and mixing the total amount uniformly.

(3) Characteristics As shown in Table 1, the Fic product of Comparative Example 1 had a gel-like (pudding-like) appearance and had poor practicality in dormitory characteristics. As shown in No. 1, it was improved from K by adding hydroxyethyl celbosu, and although two of the 20 elderly and junior high school students found it somewhat difficult, there was no problem in practical use.

In addition, Comparative Example 2 had a high viscosity, and if air bubbles were mixed in, it was difficult to remove, and good results could not be obtained.

Examples 4-59. Comparative examples 4 to 7 (1) Composition (2) M back method Prepared in the same manner as in Example 1.

(3) Properties As shown in Table 1, Example 4 was a little dry, and two people had some problems, but practically no problems were observed. In addition, in Example 6, mild erythema was observed in only one patient, and the score was 1c51! It was of a usable level.

Comparative Example 4 has a low amount of phosphoric acid salts and has a defect in sweat resistance, whereas Comparative Example 5 has a high amount of salts, which reduces the transparency and viscosity of the composition, resulting in poor adhesion. The amount of polyhydric alcohol blended was too small and the drying resistance was poor, whereas in Comparative Example 7, the amount of polyhydric alcohol blended was excessive and skin irritation was observed.

(Effects of the invention) It is clear that an acid is provided. That is, the composition of the present invention is a transparent composition and has an appropriate viscosity, thereby preventing air bubbles from being mixed in, facilitating the casing between the probe and the skin, and creating a continuous gap between the probe and the skin. It has the effect of adhering closely and maintaining the propagation of ultrasonic energy well. Furthermore, it is an excellent transparent viscous composition for ultrasonic diagnosis with good storage stability and no skin irritation.

Claims (7)

[Claims] (1) A transparent viscous composition for ultrasound diagnosis comprising a carboxyvinyl polymer salt, hydroxyethyl cellulose, disodium phosphate, monopotassium phosphate, polyhydric alcohol, and water. (2) Polyhydric alcohol is glycerin, diglycerin,
Propylene glycol, dipropylene glycol, 1,
The composition according to claim (1), which is at least one selected from the group consisting of 3-butylene glycol and polyethylene glycol. (3) The composition according to claim (1), wherein the carboxyvinyl polymer salt is blended in an amount of 0.4 to 1.2% by weight based on the total amount of the composition. (4) The composition according to claim (1), wherein hydroxyethylcellulose is blended in an amount of 0.03 to 0.8% by weight based on the total amount of the composition. (5) Disodium phosphate and monopotassium phosphate in a ratio of 1:0.
The composition according to claim 1, wherein the ratio of both is 0.2 to 2.6% by weight based on the total amount of the composition. (6) Polyhydric alcohol is 10 to 8 with respect to the total amount of the composition
The composition according to claim (1), which is blended in an amount of 0% by weight. (7) The composition according to claim (1), wherein water is blended in an amount of 60 to 85% by weight based on the total amount of the composition.