JP6778963B1 - Soft capsule film, manufacturing method of soft capsule film, and soft capsule - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a method for producing a soft capsule film containing gelatin as a film base and glycerin as a plasticizer. SOLUTION: A soft capsule film containing gelatin as a film base and glycerin as a plasticizer contains modified starch selected from acid-treated potato starch, acid-treated glutinous corn starch, and acid-treated corn starch. By doing so, a soft capsule film having the same composition except that it does not contain the modified starch is produced with a smaller degree of increase in adhesiveness at high temperatures. [Selection diagram] None

Description

The present invention relates to a soft capsule film, a method for producing the soft capsule film, and a soft capsule using the soft capsule film.

Gelatin is a unique substance that has both excellent film-forming ability and the property of reversibly changing sol-gel (gelling ability) when the temperature changes near room temperature. Therefore, gelatin is often used as a film base for soft capsules in which the film needs to be heat-sealed in the process of being manufactured by the rotary die type manufacturing apparatus.

On the other hand, the soft capsule film is required to have flexibility and elasticity. This is mainly because the contents enclosed in the soft capsule film are usually "liquids" (solutions or suspensions), and the volume changes greatly with the temperature change of the environment. If the soft capsule film has poor flexibility and elasticity, the soft capsule film may crack due to the volume change of the contents, and the contents may leak. Therefore, a plasticizer is generally added to the soft capsule film in order to enhance flexibility and elasticity, and glycerin has conventionally been widely used as the plasticizer.

However, when glycerin is contained in a soft capsule film using gelatin as a film base, it softens at high temperatures and the surface tends to adhere, and the soft capsules or the soft capsule and the storage container may adhere to each other during storage. It was.

Therefore, in the past, the applicant has proposed a technique for adding pea protein to a soft capsule film containing gelatin as a film base and glycerin as a plasticizer (see Patent Document 1). According to this technique, the degree to which the film surface becomes sticky at high temperatures can be sufficiently suppressed.

Since the above invention, the applicant has continued to study other means for suppressing an increase in adhesiveness at high temperatures with respect to a soft capsule film containing gelatin as a film base and glycerin as a plasticizer. The present invention has been made in the process of its examination.

Japanese Patent No. 3802550

As described above, the present invention is a soft capsule film containing gelatin as a film base and glycerin as a plasticizer, wherein the increase in adhesiveness at high temperature is suppressed, and a method for producing the soft capsule film. Another object is to provide a soft capsule using the soft capsule film.

In order to solve the above problems, the soft capsule film according to the present invention is
"Contains gelatin and glycerin, and
It contains modified starch selected from acid-treated potato starch, acid-treated glutinous corn starch, and acid-treated corn starch. "

The "acid treatment" is carried out by immersing the starch particles as a raw material in a dilute acid such as dilute hydrochloric acid or dilute sulfuric acid at a temperature at which the raw material is not gelatinized for a predetermined time, and then neutralizing, washing with water, and drying. It is said that by treating the starch with an acid, the amorphous portion of the starch granules is preferentially decomposed to shorten the chain.

Conventionally, modified starch has been used as a raw material for a soft capsule film, but when gelatin is not used as a film base, it is used as a film forming agent. Although the modified starch has been focused on the film-forming ability in the past, the present inventors have developed some types of acid-treated starch (acid-treated potato starch, acid-treated glutinous corn starch, and acid-treated starch). It was found that the corn starch) has an effect of suppressing an increase in the adhesiveness of the soft capsule film under high temperature, which led to the present invention.

The soft capsule film according to the present invention has the above configuration.
It can be said that "the modified starch contains 15 parts by weight to 45 parts by weight of acid-treated potato starch with respect to 100 parts by weight of gelatin". Or,
"As the modified starch, 20 parts by weight to 40 parts by weight of acid-treated glutinous corn starch is contained with respect to 100 parts by weight of gelatin." Also, or
"As the modified starch, 20 parts by weight to 25 parts by weight of acid-treated corn starch is contained with respect to 100 parts by weight of gelatin."

As will be described in detail later, even if the acid treatment is performed, if the origin of the starch is different, the amount of addition suitable for sufficiently exerting the effect of suppressing the increase in adhesiveness at high temperature is different. With this configuration, an increase in the adhesiveness of the soft capsule film under high temperature can be sufficiently suppressed.

Next, the method for producing a soft capsule film according to the present invention is
"For a soft capsule film containing gelatin as a film base and glycerin as a plasticizer,
By containing modified starch selected from acid-treated potato starch, acid-treated glutinous corn starch, and acid-treated corn starch.
A method for producing a soft capsule film, wherein a soft capsule film having the same composition except that it does not contain the modified starch is produced, and the degree of stickiness increases at a high temperature is smaller .
"As the modified starch, 15 parts by weight to 45 parts by weight of acid-treated potato starch is contained with respect to 100 parts by weight of gelatin", or "As the modified starch, acid-treated glutinous corn starch is contained in 100 parts by weight of gelatin. 20 to 40 parts by weight is contained ", also or relative, as" the modified starch, acid-treated corn starch is contained 20 parts by weight to 25 parts by weight per 100 parts by weight of gelatin "Ru Monodea ..

A soft capsule film having the above structure is produced by this production method.

Next, the soft capsule according to the present invention is
"The contents are filled in the soft capsule film described above."

As the "contents", pharmaceutical ingredients, crude drug ingredients, health food ingredients, and nutritional supplement ingredients can be used without particular limitation, and these ingredients (target substances for ingestion) are dissolved or suspended in fats and oils or oily substances. A turbid substance or a substance in which the target substance itself is oily or pasty can be used.

This composition is a soft capsule with gelatin as a film base, which is given flexibility and elasticity by glycerin, and also suppresses adhesion between soft capsules and adhesion between soft capsules and containers even when stored at high temperature. It is a soft capsule that has been made.

As described above, according to the present invention, a soft capsule film containing gelatin as a film base and glycerin as a plasticizer, and the increase in adhesiveness at high temperature is suppressed, the production of the soft capsule film. A method and a soft capsule using the soft capsule film can be provided.

Hereinafter, a soft capsule film according to an embodiment of the present invention and a method for producing the same will be described. The soft capsule film of the present embodiment contains gelatin as a film base, glycerin as a plasticizer, and modified starch. The modified starch is selected from acid-treated potato starch, acid-treated glutinous corn starch, and acid-treated corn starch.

A soft capsule provided with such a soft capsule film can be manufactured by using a rotary die type molding device, and is formed in the soft capsule film at the same time as the film stock solution preparation step for preparing the film stock solution for the soft capsule film and the molding of the soft capsule film. It can be obtained through a molding / filling step of filling and enclosing the contents and a drying step of drying the soft capsule after the molding / filling step.

In the film stock solution preparation step, gelatin, which is the film base, is dissolved in water while heating, modified starch and glycerin are added thereto, and the mixture is thoroughly stirred and mixed to prepare the film stock solution.

A rotary die-type molding device generally has a casting drum for molding a film stock solution into a film, a pair of die rolls having a molding mold formed on an outer surface, and a wedge shape for filling contents arranged between the die rolls. It mainly includes a segment and a pump that press-fits the contents into the segment and pushes the contents out from the tip of the segment.

Then, in the molding / filling step, the film stock solution is first cast on the surface of the casting drum and gelled to form a sheet. Next, the two formed sheets are fed between the pair of die rolls along the segments. Then, as the pair of die rolls rotate in opposite directions, the two sheets are heat-sealed to form a capsule that opens upward, and the contents extruded from the segment are filled therein. At the same time, the two sheets are heat-sealed at the top to form a soft capsule filled with the contents in the closed interior space. That is, by forming the undiluted film solution into a film and heat-sealing it, a soft capsule film having a closed space inside is produced, and at the same time, a soft capsule in which the contents are filled in the soft capsule film is produced.

In the drying step, the soft capsule film is dried in a humidity control dryer until it reaches a predetermined water content.

The soft capsule film of the first embodiment contains potato starch which has been acid-treated as modified starch. A film stock solution was prepared at a ratio of 100 parts by weight of water and 40 parts by weight of glycerin to 100 parts by weight of gelatin, and this was used as sample E1-0. Acid-treated potato starch was added to Sample E1-0 in different proportions to prepare a film stock solution of Samples E1-1 to E1-11. As the acid-treated potato starch, Elian GEL100 (manufactured by Ingredion Japan) was used.

For each sample, ductility, film forming property, film physical property after drying, and adhesiveness were evaluated by the following methods. The evaluation results are shown in Table 1 together with the composition.

<Ductility>
The viscosity of the film stock solution is measured, and when the viscosity is 60,000 mPa · s or less in consideration of the ease of casting, it is evaluated as "○" as having good ductility, and from 60,000 mPa · s. High cases were evaluated with "x". Here, the viscosity was measured using a B-type viscometer (No. 4 rotor, rotation speed 6 rpm) at a temperature of 60 ° C.

<Film formation>
The film stock solution was cast on a smooth surface to form a sheet having a thickness of 10 cm × 10 cm × 0.8 mm. When the sheet before drying was pulled and stretched without breaking, it was evaluated as "◯" as having an appropriate strength and excellent film forming property, and when it was not, it was evaluated as "x".

<Physical properties of film after drying>
The sheet molded in the same manner as above was dried until the water content became 8%. The dried sheet was folded in half, and when it was bent without cracking, it was evaluated as "○" as having excellent flexibility, and when it was cracked, it was evaluated as "x".

<Adhesiveness>
A sheet dried in the same manner as above was cut into a size of 1 cm × 1 cm to obtain a test piece, and 50 test pieces were placed in a glass standard bottle having a volume of 50 mL, sealed, and stored at a predetermined temperature for a predetermined time. After that, the opened bottle was turned upside down, and when all the test pieces were individually dropped from the bottle, it was evaluated as "◎" as having very good non-adhesiveness, and more than half of the test pieces were from the bottle. When individually dropped, the non-adhesiveness is evaluated as "○", and the number of test pieces that fall with the test pieces attached to each other or the number of test pieces that do not fall due to the bottle is more than half. Was evaluated as "x". There are two types of storage temperature, 50 ° C, which is considerably higher than the storage temperature of general soft capsules, and 55 ° C, which is even higher and harsh conditions, and the storage time is 24 hours, 50 hours, and 100 hours. did.

As shown in Table 1, the soft capsule film of sample E1-0 containing no modified starch has increased adhesiveness when stored at a temperature of 50 ° C. for 24 hours, and all the test pieces are replaced with other test pieces. It has adhered to the vessel wall of the bottle. On the other hand, a sample containing acid-treated potato starch at a ratio of 15 parts by weight to 45 parts by weight with respect to 100 parts by weight of gelatin is generally 50 ° C., which is a temperature considerably higher than the temperature at which soft capsules are stored. The non-adhesiveness was good or very good even when stored for a long time of 100 hours. When the ratio of acid-treated potato starch to 100 parts by weight of gelatin is 25 parts by weight to 45 parts by weight, the non-adhesiveness is maintained even when stored at 55 ° C., which is a harsher high temperature, for a long time of 100 hours. It was very good.

From this, it was considered that the acid-treated potato starch has an effect of suppressing an increase in adhesiveness of a soft capsule film containing gelatin as a film base material and glycerin as a plasticizer at high temperature. The effect tends to be greater as the proportion of acid-treated potato starch increases, but the film-forming property decreases at 50 parts by weight or more as a ratio to 100 parts by weight of gelatin, and the viscosity of the film stock solution decreases at 75 parts by weight or more. It is high and difficult to spread.

Next, the soft capsule film of the second embodiment will be described. The soft capsule film of the second embodiment contains glutinous corn starch that has been acid-treated as modified starch. Acid-treated glutinous corn starch was added to the above-mentioned film stock solution E1-0 in different proportions to prepare the film stock solution of Samples E2-1 to E2-8. Clear gum (manufactured by Roquette) was used as the acid-treated glutinous corn starch.

For each sample, ductility, film forming property, film physical property after drying, and adhesiveness were evaluated by the same method as described above. The evaluation results are shown in Table 2 together with the composition.

As shown in Table 2, a sample containing 20 to 40 parts by weight of acid-treated glutinous corn starch with respect to 100 parts by weight of gelatin is generally at a temperature considerably higher than the temperature at which soft capsules are stored. The non-adhesiveness was good or very good even when stored for a long time of 100 hours at 50 ° C. A sample in which the ratio of acid-treated potato starch to 100 parts by weight of gelatin is 25 to 40 parts by weight is not adherent even when stored at 55 ° C., which is a harsher high temperature, for a long time of 100 hours. It was very good.

From this, it was considered that the acid-treated glutinous corn starch has an effect of suppressing an increase in the adhesiveness of a soft capsule film containing gelatin as a film base material and glycerin as a plasticizer at high temperatures. The effect tends to be greater as the proportion of acid-treated glutinous corn starch increases, but when the proportion of gelatin to 100 parts by weight is 45 parts by weight or more, the viscosity of the film stock solution is high and spreading becomes difficult.

Next, the soft capsule film of the third embodiment will be described. The soft capsule film of the third embodiment contains corn starch which has been acid-treated as modified starch. Acid-treated corn starch was added to the above stock solution E1-0 in different proportions to prepare the stock solution E3-1 to E3-6. As the acid-treated corn starch, Confectionery G (manufactured by TATE & LYLE) was used. The glutinous corn starch used in the second embodiment before acid treatment contains only amylopectin, whereas the processed starch used in the third embodiment contains corn starch before acid treatment. Is a starch in which amylopectin and amylose are mixed.

For each sample, ductility, film forming property, film physical property after drying, and adhesiveness were evaluated by the same method as described above. The evaluation results are shown in Table 3 together with the composition.

As shown in Table 3, a sample containing 20 parts by weight to 25 parts by weight of acid-treated corn starch with respect to 100 parts by weight of gelatin is generally at a temperature considerably higher than the temperature at which soft capsules are stored. The non-adhesiveness was good even when stored at 50 ° C. for a long time of 100 hours. The viscosity of the film stock solution is higher than the viscosity of the film stock solution when acid-treated potato starch or acid-treated glutinous corn starch is added at the same ratio, and the viscosity of the film stock solution is 30 parts by weight or more as a ratio to 100 parts by weight of gelatin. Becomes difficult.

The acid-treated corn starch was thought to have the effect of suppressing the increase in stickiness of a soft capsule film containing gelatin as a film base material and glycerin as a plasticizer at high temperatures, but it is a very harsh temperature 55. The effect of suppressing the increase in stickiness when stored at ° C was smaller than that of acid-treated potato starch and acid-treated glutinous corn starch.

As described above, by adding acid-treated potato starch, acid-treated glutinous corn starch, or acid-treated corn starch to a soft capsule film containing gelatin as a film base and glycerin as a plasticizer. , It is possible to suppress the degree to which the soft capsule film increases the adhesiveness at high temperature.

The amount added to sufficiently exert the effect of suppressing the increase in stickiness at high temperature is 15 parts by weight to 45 parts by weight, more preferably 25 parts by weight in the case of acid-treated potato starch, as a ratio to 100 parts by weight of gelatin. By weight to 45 parts by weight, 20 parts by weight to 40 parts by weight in the case of acid-treated glutinous corn starch, more preferably 25 parts by weight to 40 parts by weight, and 20 parts by weight in the case of acid-treated corn starch. It was about 25 parts by weight.

Of the acid-treated potato starch, acid-treated glutinous corn starch, and acid-treated corn starch, the acid-treated potato starch is in the range of the ratio that sufficiently exerts the effect of suppressing the increase in stickiness at high temperature. There is an advantage that the degree of freedom of the amount of addition is high because of the wide range. Further, the acid-treated potato starch has an advantage of sufficiently exerting an effect of suppressing an increase in adhesiveness at a high temperature even with a small addition amount of 15 parts by weight with respect to 100 parts by weight of gelatin. .. Furthermore, in order to have very good non-adhesiveness when stored for a long time of 100 hours at 55 ° C., which is a very harsh temperature, acid-treated glutinous corn starch is used with respect to 100 parts by weight of gelatin. Whereas 30 parts by weight was required, the acid-treated potato starch has an advantage that the addition amount is as small as 25 parts by weight with respect to 100 parts by weight of gelatin.

As described above, acid-treated potato starch was considered to be the most advantageous in suppressing the increase in adhesiveness of the soft capsule film at high temperatures. Therefore, acid-treated potato starch was also examined. Was added. Specifically, a film stock solution was prepared using another processed potato starch instead of the acid-treated potato starch having the same composition as the samples E1-4, and used as samples E4 to E7. As the processed potato starch, sample E4 uses phosphoric acid cross-linked potato starch, sample E5 uses hydroxypropylated phosphoric acid cross-linked potato starch, sample E6 uses acetylated phosphoric acid cross-linked potato starch, and sample E7 uses acetyl. Potato starch that had been converted and treated with acid was used.

For each sample, ductility, film forming property, film physical property after drying, and adhesiveness were evaluated by the same method as described above. The evaluation results are shown in Table 4.

As can be seen from Table 4, even if the starch is a potato starch, the starch that has been processed other than the acid treatment has a higher viscosity of the film stock solution than the acid-treated potato starch even if the ratio to gelatin is the same, and the film is formed in the first place. Was difficult.

Further, for the purpose of examining acid-treated starch derived from potatoes, glutinous corn, and non-corn, acid-treated tapioca starch was also examined in the same manner as described above. As a result, a soft capsule film having good film-forming properties and film physical properties after drying could be obtained, but the effect of suppressing an increase in adhesiveness at high temperatures was small.

Although the present invention has been described above with reference to preferred embodiments, the present invention is not limited to the above embodiments, and as shown below, various improvements are made without departing from the gist of the present invention. And the design can be changed.

For example, in addition to the above components, other additives such as colorants and fragrances can be added to the soft capsule film.

Further, the soft capsule film can contain a plurality of modified starches selected from acid-treated potato starch, acid-treated glutinous corn starch, and acid-treated corn starch, and exerts the same effects as described above. It is thought that it will be done.

Claims (6)

Containing gelatin and glycerin,
It contains modified starch selected from acid-treated potato starch, acid-treated glutinous corn starch, and acid-treated corn starch .
A soft capsule film characterized by containing 20 parts by weight to 25 parts by weight of acid-treated corn starch as the modified starch with respect to 100 parts by weight of gelatin . Containing gelatin and glycerin,
It contains modified starch selected from acid-treated potato starch, acid-treated glutinous corn starch, and acid-treated corn starch.
The modified starch as, features and to Luso shift capsule shell that the acid-treated potato starch containing 15 parts by weight to 45 parts by weight per 100 parts by weight of gelatin. Containing gelatin and glycerin,
It contains modified starch selected from acid-treated potato starch, acid-treated glutinous corn starch, and acid-treated corn starch.
The modified starch as, features and to Luso shift capsule shell that the acid-treated waxy species maize starch containing 20 to 40 parts by weight per 100 parts by weight of gelatin. A soft capsule film containing gelatin as a film base and glycerin as a plasticizer.
A method for producing a soft capsule film containing processed starch selected from acid-treated potato starch, acid-treated glutinous corn starch, and acid-treated corn starch. As the processed starch, acid-treated corn starch is used as gelatin 100. By containing 20 to 25 parts by weight with respect to the weight part ,
Method for producing a more soft capsule film of the same composition except that it does not contain modified starch, <br/> features and to Luso shift capsule shell to produce a smaller soft capsules coating degree increase tackiness at elevated temperatures .. A soft capsule film containing gelatin as a film base and glycerin as a plasticizer.
Acid-treated potato starch, acid-treated waxy species corn starch, and a method for producing a soft capsule film Ru is contained modified starch selected from acid-treated corn starch, as the modified starch, acid-treated potato starch gelatin 15 parts by weight to 45 parts by weight per 100 parts by weight, or, a waxy species corn starch was acid-treated by Rukoto is contained 20 parts by weight to 40 parts by weight per 100 parts by weight of gelatin,
A method for producing a soft capsule film, which comprises producing a soft capsule film having the same composition except that it does not contain modified starch, and having a smaller degree of increase in adhesiveness at high temperature. A soft capsule in which the contents are filled in the soft capsule film according to any one of claims 1 to 3 .