JP5396125B2 - Film-forming formulation - Google Patents

Description

  The present invention relates to a film-forming preparation that is an external preparation.

  The conventional film-forming preparation forms a film on the skin, and the present applicant has already provided Patent Document 1 below. This prior art improves the percutaneous absorption of the contained drug to the affected area, enhances the local therapeutic effect, and further protects the affected area with a film to prevent external physical and chemical irritation and bacterial infection, The present invention provides a film preparation that forms a film close to the skin tissue on the required skin on the drug, and is composed of nitrocellulose dissolved in 3-methylbutyl acetate, isobutyl acetate, or acetone, or a mixture thereof. Further, a drug whose main purpose is medicinal effect is added to a solubilizing agent to which ethyl alcohol is added to form a transparent or translucent film on the skin at the application site, thereby sealing the affected area.

  By the way, the film-forming preparation of the prior art forms a film on the skin in order to volatilize or release the moisture retaining component including moisture in the skin stratum corneum at the time of vaporization of the organic solvent at the time of film formation. ), Which affects the regeneration of the skin after removal of the film, and is also very painful depending on the condition of the damaged skin. It is generally difficult to use repeatedly for a long time. It was a real recognition. To solve this problem, we believe that adding moisture to improve the moisture retention function of the stratum corneum without losing the moisture retention component of the skin, especially the skin stratum corneum, is a solution. An attempt was made to add the agent.

  However, a sufficient film is not formed on the skin after volatilization of the organic solvent of the film-forming preparation, and the film after the formation is very weak in water resistance, and the strength of the film is continuously maintained in the lifestyle using water. At present, it is extremely difficult to maintain, and since the formed coating repeats fine peeling at random on the skin, the cleanliness of the skin surface, clothes, and living space is sometimes extremely deteriorated.

WO2008 / 050491 (A1)

Film-forming preparations are more reliable and durable after application than semi-solid preparations such as conventional ointments, creams and gels, and external liquids similar to lotions, cleanliness that does not stain clothes and skin, and even when taking a bath It can be said that it is a formulation with excellent convenience that the drug cannot be taken. In addition, the film-forming preparations are easier to administer than plasters, poultices, and plasters, and there is no need to peel off or remove the drugs after use, so there is almost no medical waste. It is characterized by being friendly to the global environment. Furthermore, the frequency of occurrence of skin disorders such as rash, redness, and edema peculiar to external preparations is very low.
However, since this preparation volatilizes an organic solvent at the time of film formation, it has a feature that it simultaneously deprives moisturizing components including moisture in the skin stratum corneum during volatilization. This phenomenon causes skin damage such as rough skin and cracking of the skin after the removal of the film under long-term use conditions, and damage such as pain associated therewith.
The subject of this invention is providing the film formation type formulation which coat | covers an affected part without giving damage to the skin at the time of film formation of a film formation type formulation, and the surface has moderate adhesiveness.

  The present inventor instantly forms a film on the application part of the conventional film-forming preparation, protects the affected part with the formed film, and does not reduce the effect of the contained drug, and can damage the skin of the application part, which can be said to be a side effect (rough skin Various studies were conducted on how to avoid skin cracks) and ensure safety during administration, and experiments and trial production were repeated. And it was convinced that the problem could be solved if the conventional film-forming preparation could be prevented from depriving the skin stratum corneum during the film formation. It is impossible to add water directly as a pharmaceutical feature (if water is added to a film-forming preparation before administration, that is, before film formation, the film component reacts with water at the pre-administration stage to form a water-insoluble material. Therefore, it is inevitable that water is contained after the film is formed, and studies were made including combinations of various water-soluble polymers added for the purpose of moisture retention after the film was formed.

As a result, although there was a certain amount of limit, it was possible to form a film on the skin after application with a pharmaceutical composition to which a water-soluble polymer was added. However, the strength of the film was weaker than that of the conventional film-forming preparation, and the tendency of the film to be broken particularly in contact with moisture was recognized. It was speculated that the water-soluble polymer contained in the preparation absorbed water and expanded as a cause of this, and the balance between the film strength and the uniformity was disturbed.
Although the moisturizing property of the applied site was improved, a defect in water resistance was observed in the coating itself, and there was a doubt about the protection and effect of the affected part by the coating formation. Therefore, trial and error were repeated focusing on one point of how to maintain the moisture retaining function of the water-soluble polymer by containing water and increase the water resistance and film strength of the film after water absorption. As a result, among rosin, rosin, or rosin acid, the strength of the film formed by the formulation composition containing the water-soluble polymer is particularly increased by adding rosin in a predetermined ratio, and the conventional water-soluble polymer is As a result, the strength of the formed film after application of the film-forming preparation not contained was also increased. Furthermore, it has also been found that it has an appropriate anti-slip effect (surface adhesive force) that was not found in conventional coatings. As a result of further research based on this fact, the inventor was able to complete the present invention.

The film-forming preparation of the present invention has solved the above-mentioned problems, and the features of the present invention are as follows.
First, nitrocellulose is dissolved in a solubilizer of 3-methylbutyl acetate, isobutyl acetate, acetone, or a mixture thereof, and a predetermined amount of a water-soluble polymer is added to a solution added with ethyl alcohol, and rosin is further added. Although it is added at a predetermined ratio, it can be expected to form a film with the same quality as that of a conventional film-forming preparation, and after application to the skin, the solvent evaporates and the skin where the transparent or translucent film is applied Immediately forming on it shields the application site, enhances the transdermal absorbability of the drug and demonstrates the durability of the effect, but especially by adding rosin, the water resistance of the formed film is remarkably increased It can be used in a very safe manner with less formation of the coating film in a short period of time, less skin damage such as cracks in the finger skin, and less pain. Coating surface also comes to have a moderate viscosity as a real human skin.
Of course, like the conventional formed film, the skin is shielded by the formed film to prevent the drug from detaching from the affected area, and the skin is protected from physical stimulation such as friction and scratching of clothes. That is, a film corresponding to the defense shield is formed on the skin. In addition, after applying the film-forming preparation to the skin, it suppresses the moisture vaporization of the skin stratum corneum due to the organic solvent volatilization at the time of film formation, and prevents the moisturizing component of the skin stratum corneum from leaving, thereby improving the moisture retention of the skin after use. Maintain and prevent skin disorders such as rough skin. By preventing direct contact between the applied area and moisture, it prevents the medicinal ingredients applied by hand washing etc. from flowing out from the skin, and also prevents the loss of medicinal ingredients due to contact with clothes etc. It leads to improving sex.
Since the formed film is semi-ODT (semi-sealed) and has air permeability and moisture retention, no side effects (rash, redness, blistering, etc.) at the site of application characteristic of conventional patch preparations are observed. In addition, since the formulation of the film-forming preparation does not contain any moisture, the stability of the active ingredient is extremely high, and preservatives and interfaces that are considered to have a risk of adversely affecting the skin, which is typical of general external preparations. There is no need to use an activator.

In order to solve the above-mentioned problems, that is, the invention of claim 1, nitrocellulose is dissolved in a solubilizer of 3-methylbutyl acetate, isobutyl acetate or acetone, or a mixture thereof, and ethyl alcohol is dissolved therein. A water-soluble polymer is added to the added water-soluble polymer in order to obtain a moisture retention function within a range that is flexible but not solidified , and further enhances the water resistance of the coating and is water-soluble polymer hydroxypropylcellulose (0.5 to 10 w). / w%), 0.1-10 w / w% of rosin was added to make it possible to contain water-soluble polymers such as carboxyvinyl polymer, polyvinyl alcohol, etc., and then the solvent was volatilized. Then, the affected area is sealed by forming a transparent or translucent film on the skin at the application site, and contained by the semi-ODT effect (semi-sealing effect). The transdermal absorbability is increased, the volatility of the volatilized drug is controlled (suppressed), the sustained effect of the contained drug is improved, and the persistence of the effect is further improved. It is a film-forming preparation.
A second aspect of the present invention, the friction coefficient and strength of the film in said dissolution agent, acetylated hyaluronic acid to adjust the flexibility, beeswax, carnauba wax, lanolin, and added pressure to the one or more selected from a silicone The film-forming preparation according to claim 1, wherein
According to the invention of claim 3, in order to increase the strength and flexibility of the film during film formation and the ODT effect in the solubilizer, perilla oil, sesame oil, sesame oil, olive oil, horse oil, hinoki oil, castor oil The film-forming preparation according to claim 1, comprising at least one selected from natural oils and synthetic silicone oils.
The invention according to claim 4 is the film-forming preparation according to claim 1, wherein the water-soluble polymer is at least one selected from hydroxypropylcellulose, carboxyvinyl polymer, and polyvinyl alcohol.

As described above, according to the film-forming preparation of the present invention, nitrocellulose is dissolved in a solubilizer of 3-methylbutyl acetate, isobutyl acetate, acetone, or a mixture thereof, and further added with ethyl alcohol. The rosin is added to the preparation with various moisturizing ingredients added with the desired medicinal ingredients and repellent ingredients. After applying to the skin, the organic solvent is volatilized, and the moisturizing ingredients contain moisture from the skin stratum corneum A transparent or translucent film is formed on the skin while keeping the skin moisturizing function while suppressing the separation of the skin as much as possible. As a result, the application site is semi-sealed and protected, and the percutaneous absorbability of the ingredients is increased, thereby improving the effect and its durability, protecting the skin from physical irritation caused by clothes and scratching, and further patching Prevents rashes such as redness and edema formation caused by skin irritation, which are often seen in skin. Occurrence and exacerbation of inflammation caused by scratching the affected area can be prevented by the occurrence of itching caused by skin irritation, which is often observed in external preparations in the worst case.
Furthermore, since the organic solvent that volatilizes at the time of the formed film has a sterilizing effect, it becomes possible to simultaneously sterilize the affected area. An extra bactericidal agent is not required for skin sterilization of wound sites and infected sites, and is an optimal dosage form.

Even with the base alone, it forms a film on the skin where the plaster is thinly applied to protect the skin itself while maintaining the moisture retention of the skin, and protects the skin from physical irritation such as rubbing with clothes and plants. To do. That is, the formed coating itself can be a tough second artificial stratum corneum. That is, by adding rosin to the film-forming preparation, it works to solve the above-mentioned problems of the film formed on the skin, and further it can be protected from being bitten by mosquitoes and insects.
Further, by adding a water-soluble polymer, it is possible to suppress detachment to the moisturizing component, prevent skin damage by the water retention function of the water-soluble polymer at the time of use, and further suppress skin damage due to continuous use.

[Table 4] is a table showing the water resistance test results of the formed film of the film-forming preparations of Example 1 and Comparative Examples 1 and 2 of the present invention, [Table 5] is a table showing the skin damage test results of the film-forming preparations of Example 1 and Comparative Examples 1 and 2 of the present invention. It is a figure of [Table 6] which tabulated the anti-slip | skid test result of the film formation preparation of Example 1 of this invention and Comparative Examples 1 and 2.

In the present invention, a rosin is added to a prior art film-forming preparation at a predetermined ratio, and the formation of a film with the same quality as described above can be expected with rosin alone or in combination, and the solvent is volatilized after being applied to the skin. Realizes that the application site is shielded by instantly forming on the skin where the transparent or translucent film is applied, and the percutaneous absorption of the drug is enhanced, and the effect is sustained. It is.
Although the proof of action and effect is somewhat inferior to the case of using rosin alone, rosin acid equivalent to rosin, rosin, or a mixture thereof may be used instead of rosin.

Examples of the film-forming preparation of the present invention will be described below.
Preferred examples of the film-forming preparation of the present invention will be described. First, the blending ratio of Example 1 is shown in the following [Table 1].
[Example 1]
[Table 1]
[Composition ratio]
Nitrocellulose: 7.0 w / w%
Hydroxypropylcellulose ... 1.0w / w%
Ethyl alcohol ... 70.0 w / w%
3-methylbutyl acetate: 5.0 w / w%
Acetone: 10.0 w / w%
Rosin …… 3.0w / w%
Silicone: 2.0w / w%
Sesame oil ... 1.0w / w%
Castor oil ... 1.0w / w%
Total: 100.0 w / w%

[Preparation method]
The film-forming preparation of this example was prepared by the following procedure so as to achieve the above composition ratio.
First, after nitrocellulose and hydroxypropylcellulose were dissolved in 3-methylbutyl acetate, acetone was further added and stirred well at room temperature. Next, ethyl alcohol was added to this solution and stirred well, then silicone, sesame oil, castor oil, and finally rosin were added in small portions under sequential stirring. After stirring and kneading for 3 hours, the solution was sealed for 12 hours. Manufactured by standing at room temperature.
Here, the appropriate amount of rosin w / w% (% by weight) is 0.1% to 10w / w%, but as will be described later, the effect cannot be confirmed at 0.1w / w% or less. When it exceeds w%, the viscosity becomes high, it becomes difficult to form a film, and skin irritation occurs. Therefore, 1 to 5 w / w% is more preferable. In addition, the appropriate amount of nitrocellulose is 5 to 10 w / w% for film formation, but the w / w% of rosin that obtains the best effect varies somewhat depending on this value, but in any case 0.1% to 10 w The initial effect can be obtained in the range of 1 / w%, more preferably 1-5% w / w%. Here, if the w / w% of nitrocellulose increases in the range of 5 to 10 w / w%, the w / w% of rosin decreases by 0.1% to 10 w / w% in the range of 0.1 to 10 w / w%. If the w / w% of nitrocellulose decreases in the range of 5-10 w / w%, the w / w% of rosin increases in the range of 0.1% to 10 w / w%. However, the fluctuation is slight.
The rosin used in this example is a natural cured resin extracted from oleoresin such as pine tree and purified, and has an acid value of 150 to 177 and accord with the Japanese Pharmacopoeia with an ash content of 0.1% or less. is there. In addition to rosin, rosin acid equivalent to rosin, rosin, or a mixture of these may be used, but the results show that the effects and effects are somewhat inferior compared to rosin alone. did.

In Example 1, 7.0% w / w of nitrocellulose as a film-form film forming material was used, but as described above, an appropriate amount is 5.0 to 10.0w / w. Similarly, as a film forming material, ethyl alcohol is 60.0 to 80.0 w / w%, preferably 70.0 w / w%, and 3-methylbutyl acetate is 3.0 to 8.0 w / w%, preferably 5. 0 w / w%, acetone may be dissolved 8.0 to 12.0 w / w%, preferably 10.0 w / w%.
Hydroxypropyl cellulose, which is a water-soluble polymer for moisturizing, etc., is 0.5 to 3.0 w / w%, and if it is 0.5 w / w% or less, it lacks flexibility when used. If it is / w% or more, it solidifies, preferably 1.0 to 2.0 w / w%, more preferably 1.0 w / w%. Furthermore, the silicone for adjusting the coefficient of friction, strength, and flexibility is 1.0 to 3.0 w / w%, preferably 2.0 w / w%, so as to increase the strength and flexibility of the film and the ODT effect during film formation. In order to make sesame oil, 0.5 to 2.0 w / w%, preferably 1.0 w / w%, and similarly castor oil 0.5 to 2.0 w / w%, preferably 1.0 w / w%. What is necessary is just to add little by little under sequential stirring.

The mixing ratio of Comparative Example 1 as compared with Example 1 of the present invention is shown in [Table 2].
[Comparative Example 1]
[Table 2]
[Composition ratio]
Nitrocellulose: 7.0 w / w%
Hydroxypropylcellulose ... 1.0w / w%
Ethyl alcohol ... 73.0w / w%
3-methylbutyl acetate: 5.0 w / w%
Acetone: 10.0 w / w%
Silicone: 2.0w / w%
Sesame oil ... 1.0w / w%
Castor oil ... 1.0w / w%
Total: 100.0 w / w%

[Preparation method]
The film-forming preparation of Comparative Example 1 was prepared in the following procedure in the same manner as in Example 1 so that the composition ratio was as described above.
Nitrocellulose and hydroxypropylcellulose were dissolved in 3-methylbutyl acetate, and then acetone was further added and stirred well at room temperature. Next, after adding ethyl alcohol to this solution and stirring well, silicone, sesame oil, and castor oil are added in small portions under stirring, and stirred and kneaded for 3 hours, and then left at room temperature for 12 hours in a sealed state. Manufactured.

The blending ratio of Comparative Example 2 as compared with Example 1 of the present invention is shown in [Table 3].
[Comparative Example 2]
[Table 3]
[Composition ratio]
Nitrocellulose: 7.0 w / w%
Ethyl alcohol ... 74.0 w / w%
3-methylbutyl acetate: 5.0 w / w%
Acetone: 10.0 w / w%
Silicone: 2.0w / w%
Sesame oil ... 1.0w / w%
Castor oil ... 1.0w / w%
Total: 100.0 w / w%

[Preparation method]
Similarly to Comparative Example 1, the film-forming preparation of Comparative Example 2 was also prepared by the following procedure so as to achieve the above composition ratio. After nitrocellulose was dissolved in 3-methylbutyl acetate, acetone was further added and stirred well at room temperature. Next, after adding ethyl alcohol to this solution and stirring well, silicone, sesame oil, and castor oil were added in small portions under sequential stirring, followed by stirring and kneading for 3 hours, and then allowed to stand at room temperature for 12 hours in a sealed state. Manufactured.

[Water resistance test]
The water resistance of the formed film of the film-forming preparation of the Example produced by the above composition and adjustment method was verified under the following conditions.
(1) Subject: Example 1 (the above-mentioned Example preparation: hereinafter referred to as “Example product”)
Control product: Comparative Example 1 and Comparative Example 2
(2) Test method:
1 ml of each sample collected using a dropper is dropped on a slide glass (thickness: 0.9 to 1.2 mm, area: 76 × 26 mm), and a constant thickness is applied onto the slide glass using a cotton swab. It was applied evenly. After 5 minutes, hot air drying was performed for 10 seconds using a drier from the non-coated part (back surface) of the slide glass. Next, the dried slide glass was immersed one by one in a fixed alignment container filled with purified water heated to about 30 ° C. Thereafter, the slide glass soaked every day until the seventh day was taken out, the state of the film formed on the slide glass was observed, and the degree of peeling of the film was evaluated according to the following evaluation criteria. Furthermore, after adding 1 w / w% of a surfactant (Tween 80) to warm water and stirring well, an immersion test was performed under the same conditions as described above, and evaluation was performed according to the following evaluation criteria.

Evaluation criteria: Normal (almost no damage): 5 points
Slightly damaged (10% or less): 4 points
Partially damaged (10-20%): 3 points
Slightly damaged (20-50%): 2 points
Very damaged (50% or more): 1 point
Almost damaged (90% or more): 0 points

(3) Test results The water resistance test results of the formed coating are shown in [Table 4].
As shown in [Table 4], when immersed in warm water, no dropout of the film was observed during the test period of 7 days in the example product of Example 1 of the present invention. On the other hand, in Comparative Example 1, there was a slight tendency of the film to fall off from the first day, and on the second day, there was an example where the film was completely dropped. It dropped out completely. In Comparative Example 2, there was no change in the coating until the second day, but a slight tendency to fall off was observed from the 3rd to 4th days until the fifth day. confirmed.
In the test in which the specimen was immersed in a solution in which a surfactant was added to warm water, there were no examples in which the coating film dropped or damaged during the test period of 7 days in the example products. On the other hand, in Comparative Example 1, all of the coatings were removed on the first day of the test, and all of the coatings were removed on the second day. In Comparative Example 2, the film did not drop off at all on the first day of the test, but a part of the film on the second day was observed to drop off, and the tendency became stronger over time. Dropped out.
From the above results, it was confirmed that the formed product did not fall off during the test period of 7 days even in the case of being immersed in warm water and warm water to which a surfactant was added, and further improving the water retention of the skin. It was demonstrated that the characteristics of the coating were dramatically improved even when compared with Comparative Example 1 formulated as an object and Comparative Example 2 as a conventional film-forming preparation formulation.

[Skin damage test]
The effect on skin damage due to moisture loss of the skin stratum corneum of Example 1 produced by the above composition and preparation method was verified under the following conditions.
(1) Subject: Example 1 (Formulation of Example 1 above: hereinafter referred to as “Example product”)
Control product: Comparative Example 1 and Comparative Example 2
(2) Subject: Female aged 22-35 (3) Test method:
Three kinds of subjects were placed in three plastic containers each having a diameter of 2.5 cm and a capacity of 30 ml, and these were designated as A (Example product), B (Comparative example 1), and C (Comparative example 2). Next, immerse the subject's right index finger to A, middle finger to B, and ring finger to C to the first joint of the finger. After a few seconds, remove each finger from the container and let it dry for about 5 minutes without using your hand. I let you. This treatment was performed every morning at 10:00, and after 24 hours, the degree of skin damage at the tip of the finger was determined according to the following criteria. This operation was carried out for 7 consecutive days.
During the test period, the subjects were allowed to live without any restrictions on their normal living behavior.
Criteria: No skin cracking / pain: 0 points
No minor skin cracks / pain: 1 point
Mild skin cracks / pain: 2 points
Moderate skin crack / pain: 3 points
Strong skin crack / pain: 4 points

(4) Test results:
The test results of the effect on skin damage are shown in [Table 5]. As shown in [Table 5], the product of Example 1 of the present invention was repeatedly immersed in the index finger for 7 days continuously, but no cracks were confirmed in the finger skin, and therefore accompanied by skin cracks. There was no complaint of pain. In contrast, Comparative Example 1 showed no particular change in the skin of the middle finger until the third day after the start of the test, but two cases of mild skin cracking and pain were observed on the fourth day. After that, the degree of symptom and the number of cases gradually increased although they were mild. On the last day of the study, all cases showed mild skin cracking and painful symptoms. In Comparative Example 2, mild skin cracking without pain in the ring finger was observed in 2 cases from the first day of the test, and the worsening of the symptoms progressed at a rate twice as fast as Comparative Example 1 from the second day. From the first day, pain developed in all cases, the symptoms of pain persisted until the last day of the test, and the degree of skin cracking became almost intense.
From the above results, compared to Comparative Examples 1 and 2, the Example product did not affect the fingertip skin at all even after 7 days of continuous use, so it is a film-forming preparation that can be used very safely. It was considered.

[Anti-slip test]
The anti-slip effect of the coating itself after forming the coating of Example 1 produced by the above composition and preparation method was verified under the following conditions using the Korogari Tack test method.
(1) Subject: Example 1 (Formulation of Example 1 above: hereinafter referred to as “Example product”)
Control product: Comparative Example 1 and Comparative Example 2
(2) Preparation of specimen: Example product and Comparative Examples 1 and 2 were each uniformly applied on a glass plate at a rate of 0.1 g / 1 cm × 1 cm) using a cotton swab, and after natural drying for 3 minutes, After drying for 30 seconds from the back surface of the glass using a drier, it was immersed in an immersion tank filled with purified water. After 3 hours, the specimen was taken out from the immersion tank, and the film formed on the glass plate using tweezers was carefully peeled off using tweezers, and the water was removed to make each specimen.
(3) Test method: The test was carried out in accordance with the Kologaritak test method (pharmaceutical production guideline). A coating film (2cm x 5cm) is set on the slope end of the tester with an inclination angle of 30 degrees, and steel balls (No.1: diameter 3.2mm, weight 0.13g, No.2: diameter 4.8mm, from the upper end of the tester) The rolling distance was measured by measuring the position where the steel ball stopped on the specimen from the end of the slope. The index judgment was that the shorter the rolling of the steel ball on the subject, the better the adhesive strength.

(4) Test results:
Table 6 shows the test results of the anti-slip effect of the coating itself after the coating is formed. As shown in [Table 6], when a relatively light steel ball No. 1 was used, in the example product of Example 1 of the present invention, all balls were 0.8 on the formed coating after 5 trials. Stopping at ˜1.5 cm, the rolling distance averaged 1.14 cm. When relatively heavy steel ball No. 2 was used, all the balls stopped at 2.0 to 2.8 cm on the formed film after 5 trials, and the rolling distance averaged 2.58 cm. there were.
On the other hand, in Comparative Examples 1 and 2, which is a control, none of the steel balls of No. 1 and 2 stopped on the formed film in 5 trials.
From the above results, it was clarified that the example products have moderate tackiness and roughness as in the case of actual human skin, compared to the conventional film-forming preparations and the moisture-retaining function-improving coatings. .

As described above, the characteristics of the film-forming preparations of the examples of the present invention are that nitrocellulose is dissolved in a solubilizer of 3-methylbutyl acetate, isobutyl acetate, acetone, or a mixture thereof, and further ethyl alcohol is dissolved. A rosin is added to the base added with various repellent ingredients and various moisturizing ingredients. With this configuration, in particular, by adding rosin, the water resistance of the formed film is remarkably improved, and the formed film is less likely to fall off in a short period of time. There is little onset of pain and it can be used very safely, and the surface of the coating also has moderate stickiness and roughness like real human skin. In this way, water-soluble polymers can be added, so that moisturizing ingredients can be prevented from detaching, and the water-holding function of the water-soluble polymer during use can prevent skin damage, and further suppress skin damage due to continuous use. You can also.
In addition, as with conventional film-forming preparations, the organic solvent is volatilized after application to the skin, and it is transparent while maintaining the skin moisturizing function by minimizing the detachment of the moisturizing ingredients including moisture in the skin stratum corneum. A transparent film is formed on the skin. As a result, the application site is semi-sealed and protected, and the percutaneous absorbability of the ingredients is increased, thereby improving the effect and its durability, protecting the skin from physical irritation caused by clothes and scratching, and further patching Prevents rashes such as redness and edema formation caused by skin irritation, which are often seen in skin. In the worst case, the occurrence of itch caused by skin irritation, which is often observed in external preparations, causes the occurrence or exacerbation of inflammation due to the scratching of the affected area, which can be prevented. Furthermore, since the organic solvent that volatilizes at the time of the formed film has a sterilizing effect, it becomes possible to simultaneously sterilize the affected area. An extra bactericidal agent is not required for skin sterilization of wound sites and infected sites, and is an optimal dosage form.
Furthermore, in the case of pathological skin, such as athlete's foot, the sterilization of the affected area with alcohol contained in the base material, moisture in the exudate from the pathological skin tissue accompanying alcohol volatilization, and water from the pathological skin tissue itself By depriving it, it is possible to suppress the growth of athlete's foot bacteria and increase the content of the antibacterial agent. Furthermore, infection to a third party can be prevented by enclosing the affected bacteria with a coating.

In other words, when a drug substance is included in the base material, it improves the percutaneous absorbability to the affected area, enhances the local therapeutic effect, and further protects the affected area with a film, so that it can be physically and chemically applied from the outside. Prevents irritation and bacterial infection. After application to the skin, the solvent evaporates and forms a transparent or translucent film on the affected area's skin to seal the affected area. Increase the efficacy of the affected area by preventing direct contact between the affected area and water, and at the same time, prevent side effects (rash, redness, blistering, etc.) of the affected area.
Even with the base alone, it forms a film on the skin where the plaster is thinly applied to protect the skin itself while maintaining the moisture retention of the skin, and protects the skin from physical irritation such as rubbing with clothes and plants. To do. That is, the formed coating itself can be a tough second artificial stratum corneum. For this reason, by covering the applied drug with a film, it is possible to prevent the outflow of the drug due to bathing or showering, and the sustainability of the effect can be expected. Furthermore, the infection and discomfort to third parties via water are eliminated.
In addition, although this invention is characterized by adding rosin alone, you may use rosin acid equivalent to rosin, rosin, and what mixed these instead of rosin. However, its action and effect are somewhat inferior compared to the case of using rosin alone.
Thus, it goes without saying that the present invention is not limited to the above-described embodiments as long as the features of the present invention are not impaired.

Since the film-forming preparation of the embodiment of the present invention forms a film on the skin, the role of the stratum corneum of the skin (protection against physical and chemical penetration from the outside) and the control of sweating can be achieved even as a preparation containing no drug. It is possible to prevent body odor (sweat odor) by sterilizing and disinfecting with the base ingredients (ethyl alcohol, etc.), and to contain one or more moisturizers to improve the moisture retention of the skin after film formation In addition, when the skin is exposed, the film-forming preparation of the example can be applied to the skin, so that mosquitoes and insects cannot pierce the skin, and can be used as an insect bite protective agent. . In this case, the rosin itself is more effective because it has a repellent effect against mosquitoes and insects.
In addition, by applying a poultice to the hands during sports, the formed coating suppresses sweating, suppresses the generation of odors, exhibits an anti-slip effect on the limbs, and further enhances the toughness of the skin, thereby improving the palms and feet of the hands. Guarding the bottom may prevent sports problems and improve performance.

Claims (4)

Nitrocellulose is dissolved in 3-methylbutyl acetate, isobutyl acetate or acetone, or a mixture thereof, and ethyl alcohol is added to the nitrocellulose so that it has flexibility but does not solidify. film forming type formulation adding a water-soluble polymer, characterized by further added 10w / w% of rosin from 0.1 to. The film-forming preparation according to claim 1, wherein at least one selected from acetylated hyaluronic acid, beeswax, carnauba wax, lanolin and silicone is added to the solubilizer.   The said solubilizer contains at least one selected from perilla oil, sesame oil, sesame oil, olive oil, horse oil, hinoki oil, castor oil natural oil, and synthetic silicone oil. Film-forming preparation.   The film-forming preparation according to claim 1, wherein the water-soluble polymer is at least one selected from hydroxypropylcellulose, carboxyvinyl polymer, and polyvinyl alcohol.

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