JP2009040716A - Soft capsule film composition - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a soft capsule film composition which is a capsule film composition prepared by using a non-animal raw material as a main raw material, is inhibited in the stickiness on the surface of a film sheet, and has a film strength capable of enduring continuous production in a factory production of a rotary die type filling machine, etc., and enables the production of a good soft capsule preparation having a high bonding property. <P>SOLUTION: The soft capsule film composition comprises a mixture of a processed starch, native type gellan gum, deacylated gellan gum, a plasticizer and water, and provides mix-using the native type gellan gum with deacylated type gellan gum and blending dextrin with the processed starch. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a coating composition for soft capsules applied in a wide range of fields such as foods, pharmaceuticals, quasi drugs, and cosmetics. In particular, gellan gum and starch are used as soft capsule coating compositions derived from non-animals. The present invention relates to a soft capsule film composition used and a soft capsule manufacturing method using the same.

  As shown in FIG. 1, a rotary die filling method, which is one of the methods for producing soft capsules, is a sheet-like method by spreading a coating composition solution on a cooled rotating drum on both sides of a capsule filling machine. Then, the coating sheet is fed between rotating cylindrical molds (die rolls), and the contents are press-fitted by a piston of a pump interlocking therewith, and a capsule is formed by cutting both molds. At this time, the film sheet is heated to an appropriate temperature by the segment, and is bonded by pressure and heat sealing to form a soft capsule.

  The properties required for the coating composition to be formed by this method are mechanical strength that can withstand continuous processes from forming to filling of the coating sheet and sol-gel thermoreversibility for heat sealing, or adhesion by pressure bonding. It is sex. Conventionally, gelatin having these characteristics at a high level has been used as a soft capsule film composition.

On the other hand, in recent years, there has been a demand for a non-animal soft capsule coating composition that replaces gelatin mainly made from bone and skin of cattle, pigs, etc., due to concerns such as BSE problems, religious reasons, and allergies. I came. As an alternative to the gelatin, there is a soft capsule film composition using agar or a seaweed polysaccharide such as carrageenan as disclosed in Patent Document 1. In addition, as shown in Patent Documents 2 to 6, soft capsule film compositions using gellan gum, which is a polysaccharide produced by microorganisms, have been proposed.
Special table 2003-504326 JP-A-6-329833 JP2005-170929 JP2007-153851 JP2005-281687 JP2007-153889

  The following problems remain in the soft capsule film composition using gellan gum, which is attracting attention as a polysaccharide having a gel forming action other than carrageenan derived from seaweed, and the production of the soft capsule.

  In the conventional patent documents 2 to 6, native gellan gum alone or a mixture of native gellan gum and deacylated gellan gum, or other native polymer gelling agents such as native gellan gum and agar, carrageenan, etc. together with starch and plasticizer In general, a film sheet made of starch using native gellan gum as the main gelling agent is in contact with the rotating drum. A die roll that has a lot of stickiness compared to the back side and rotates the surface of the sticky film sheet when it is manufactured using the rotary die filling machine widely used as the existing soft capsule manufacturing equipment described above. Can't be encapsulated due to adhesion or weak adhesion even if barely encapsulated It has become a possible problem that and continuous molding can be difficult. The rotary die-type filling machine is designed to be suitable for filling and molding soft capsules consisting of a gelatin film with a lot of stickiness on the back side of the film, which is the opposite of the film sheet using native gellan gum. This can be a serious problem when soft capsules using gellan gum are manufactured by utilizing existing rotary die type filling machines without major modification of facilities.

  The reason why the film sheet made of native gellan gum and starch exhibits such properties is considered as follows. That is, since the gelation temperature of the film sheet using native gellan gum is considerably higher than that of gelatin or the like, when forming the film sheet on the rotary drum of the rotary die filling machine, in the vicinity of the surface of the film sheet, A place where gelation has progressed due to rapid air cooling at room temperature and a place slightly delayed are caused, and the gel state of the sheet becomes uneven and insufficient, resulting in a sticky gel. On the other hand, on the inner surface (back surface) of the film in contact with the rotating drum, there is less air cooling than the surface and there is also heating from the drum, and the gel gels slowly and uniformly, forming a firm and less sticky sheet surface It is thought that will come to do.

  Even in the case of a film sheet made of native gellan gum, deacylated gellan gum and starch, depending on the formulation, the film strength does not reach a mechanical strength that can withstand continuous production, and breaks during the capsule filling process. In some cases, the adhesive strength at the time of pressure bonding is low, and inconvenience that good adhesiveness cannot be obtained may occur.

  Gellan gum is a gelling agent having a higher viscosity than gelatin and other vegetable polysaccharide gelling agents. In the production of a soft capsule coating composition using gellan gum, this is mixed with starch. When preparing a coating composition by heating and dissolving, the viscosity becomes very high, the operability at the time of capsule production (homogeneous mixing operability for uniformly mixing the compositions with each other) becomes very poor and the desired concentration is difficult to obtain. Can be mentioned. Particularly in the production of soft capsules, it is necessary to increase the solid content concentration from the viewpoint of the film strength. However, if the concentration is increased, the viscosity of the composition solution increases, so that the operability deteriorates, and further on an industrial scale. However, there are problems such as the need for major changes in machinery and equipment.

  Furthermore, since a capsule film using a starch-based material has a hygroscopic property, a phenomenon in which capsules adhere to each other, that is, so-called blocking easily occurs. Blocking is a phenomenon often seen even in conventional capsule films made mainly from gelatin, and there is a strong demand for solving this problem.

  The present invention has been made in view of the above-mentioned problems, and is a soft capsule film composition using gellan gum derived from a non-animal raw material, including the use of existing soft capsule filling and manufacturing equipment such as a rotary die filling machine. In industrial soft capsule production, reduce the stickiness of the coating sheet surface, increase the mechanical strength of the coating sheet to make it difficult to break, and stably produce soft capsules with good adhesion by pressure bonding For the purpose.

  The present invention has the above-described problems even when there are only examples of the preparation of a soft capsule film sheet and examples of rotary die filling production, as seen in the examples of conventional patent documents 2 to 6. Unlike the example presumed to have, it aims to solve those problems and to produce non-animal derived soft capsules on an industrial scale, and has the following constitution as means for solving the problems Adopted. That is, the soft capsule film composition of the present invention is formed by mixing modified starch, native gellan gum, deacylated gellan gum, a plasticizer, and water. The modified starch is at least one selected from the group consisting of starch derivatives, starch degradation products, dextrins, and physically modified starches, and the amount of the modified starch added to the soft capsule coating composition is at the coating liquid stage before drying. It is 20 to 50% by weight, more preferably 25 to 45% by weight, and it is a soft capsule film composition in which at least 20% or more, more preferably 40% or more of the amount of the modified starch is dextrin. And

  As used herein, modified starch refers to starch that has been subjected to physical, chemical or enzymatic processing, and does not include unmodified (also referred to as unmodified or unmodified) starch. Unprocessed starch often has a higher molecular weight than modified starch, and when blended in a capsule coating composition, it has low solubility and may not dissolve sufficiently even after heating and dissolving operation. It remains in the film and deteriorates the properties of the coating sheet. Moreover, the viscosity of the film composition solution at the time of dissolution is high and the operability is deteriorated. Furthermore, unprocessed starch tends to cause a so-called aging phenomenon such as white turbidity, water separation, and gelation after dissolution of the paste, which may impair the stability of the capsule film sheet. In addition, since raw starch generally has low transparency after dissolution by heating, it can be a factor in increasing the opacity of a capsule film using the raw starch. Processed starch, on the other hand, has a wide variety of processing methods, and by selecting functionally suitable ones, the molecular weight is relatively smaller than that of unprocessed starch, solubility and low viscosity. It is possible to select a material that is superior in terms of stability, low humidity, and transparency. For this reason, modified starch is used in the present invention.

  Dextrin has a relatively low molecular weight compared to starch, and it has been found by extensive studies that a film sheet comprising a composition with gellan gum of the present invention using the dextrin has high drying properties and low hygroscopicity. . By adding this as one of the modified starches in the coating composition, the stickiness of the coating sheet is suppressed and good capsule adhesion is possible. Moreover, the obtained soft capsule is also low hygroscopic and blocking is also suppressed. Dextrins generally have a lower viscosity than starch, and can reduce the viscosity when the soft capsule film composition is dissolved by heating, thereby improving the operability during dissolution by heating. Furthermore, aqueous solutions in which dextrins are dissolved are generally highly transparent, and it is expected that the transparency of soft capsules will increase.

  A suitable amount of dextrin to the modified starch is at least 20% or more, more preferably 40% or more. Compared to the case of modified starch alone without adding dextrin, when dextrin is added to the modified starch formulated in the soft capsule film composition, the capsule film starts at around 20% of the dextrin in the modified starch. The stickiness of the sheet is lowered, and the strength of the coating sheet and the adhesiveness of the capsule are also improved. Furthermore, when the proportion of dextrin exceeds 40%, it has been found that all of the films are in a good state in terms of stickiness of the coating sheet, sheet strength, capsule adhesion, and blocking inhibition. Moreover, the viscosity at the time of heat-dissolution of a soft capsule membrane | film | coat composition fell with the increase in dextrin, and the operativity improved.

  By coating the modified starch containing dextrin blended in the above blending amount into the soft capsule coating composition in the range of 20 to 50% by weight, more preferably 25 to 45% by weight in the coating liquid stage before drying. The adhesiveness of the sheet is improved, and favorable capsule molding becomes possible.

  Such dextrin is at least one selected from the group consisting of enzyme-modified dextrin, white dextrin, yellow dextrin, British gum, and highly branched cyclic dextrin.

  An index representing the degree of starch degradation is the DE value: percentage of direct reducing sugar converted to glucose in the solid content, which is sometimes used to indicate the molecular weight of dextrin. As the DE value increases, starch degradation proceeds and the molecular weight decreases. In the dextrin used in the present invention, the DE value is preferably 10 or less. When many DE values greater than 10 are used, the strength of the resulting film sheet may be reduced.

  The blending amount of the gellan gum is 1.5 to 6% by weight of the native gellan gum and 0.04 to 3% by weight of the deacyl gellan gum. In this case, the blend of the native gellan gum and the desacyl gellan gum is mixed. The mixture is used so that the ratio of the amounts is 10: 9 to 99: 1, more preferably 2: 1 to 30: 1. In particular, in order to obtain a soft capsule film that is soft and highly elastic, it is necessary to use more native gellan gum that forms a soft and stretchable gel than a deacylated gellan gum that forms a hard and brittle gel.

  By mixing and using native gellan gum and deacyl gellan gum in such a blending range, the soft capsule film composition can obtain high mechanical strength and elasticity, and can be continuously produced by a rotary die filling machine. Even in a typical process, breakage or the like does not occur. The starch-based film sheet containing native gellan gum is different from other natural polymer gelling agents such as gelatin and carrageenan, and the sheet has a sticky surface compared to the back surface. Therefore, as described above, in the case of the rotary die type filling, the film sheet adheres to the die roll at the time of capsule filling and becomes a factor that cannot be formed. At this time, if deacylated gellan gum is added to native gellan gum and mixed to form a soft capsule film sheet made of starch, deacylated gellan gum has the property of forming a less sticky gel compared to native gellan gum. The stickiness of the sheet surface is suppressed. In addition, this addition adds elasticity to the physical properties of the sheet, which was only stretched softly with native gellan gum alone. Thus, the mixed use of native gellan gum and deacylated gellan gum is effective in suppressing stickiness of the coating sheet and improving elasticity.

  In the present invention, the plasticizer is one or more selected from the group consisting of glycerin, sugar alcohol, propylene glycol, polyethylene glycol, monosaccharide and disaccharide, and by adding this plasticizer, Flexibility is imparted and the impact resistance of the capsule at low temperatures is improved.

  In the step of forming the film of the soft capsule film composition of the present invention into a film sheet by spreading it on a rotating drum such as a rotary die type filling machine, the film is formed by heating the rotating drum to 30 to 80 ° C. A soft capsule having sufficient strength can be manufactured by adding mechanical strength and adhesive strength for pressure bonding.

  The soft capsule coating composition of the present invention comprising a mixture of modified starch, native gellan gum, deacylated gellan gum, plasticizer and water is used as a mixture of native gellan gum and deacylated gellan gum, as well as in the modified starch. By blending so that the proportion of dextrin occupying at least 20% or more, more preferably 40% or more, the coating sheet surface can be prevented from stickiness and can withstand continuous production in factory production such as rotary die filling machines. It gives sheet strength and enables production of good soft capsules with high adhesiveness.

  In addition, by using dextrin with low moisture absorption and quick drying, inhibition of blocking of the capsule after drying can be expected.

  The soft capsule film composition of the present invention is used for the film of soft capsules used in pharmaceuticals, quasi drugs, foods, health foods, cosmetics, etc., and it contains modified starch, native gellan gum, Acyl gellan gum, plasticizer, and water are mixed at a predetermined mixing ratio.

  Gellan gum is a heteropolysaccharide produced outside the cell by a microorganism called Pseudomonas elodea. It has four types: 1-3 linked glucose, 1-4 linked glucuronic acid, 1-4 linked glucose, and 1-4 linked rhamnose. The sugar is a repeating unit and bound linearly. Among them, those in which an acyl group is not bonded to the above-mentioned saccharides constituting the polysaccharide are called deacylated gellan gums, and generally have a property of forming a hard and brittle gel. On the other hand, in the repeating unit, one in which an acetyl group and a glyceryl group are bonded to 1-3 bonded glucose is called native gellan gum and has a property of forming a soft and stretchable gel. Examples of the native gellan gum include “Kelcogel (registered trademark) HT” and “Kelcogel LT100” under the trade names, and examples of the deacyl gellan gum include “Kelcogel” and “Kelcogel F” under the trade names (all of which are CP Made by Kelco).

  The modified starch is one or more selected from the group consisting of starch derivatives, starch degradation products, dextrin, and physically modified starch. Among them, starch derivatives are raw starch such as corn starch, tapioca starch, waxy corn starch, potato starch, rice starch, wheat starch, sago starch, oxidized, acid treated, acetylated, etherified, esterified, phosphoric acid crosslinked, Those obtained by performing chemical processing of at least one of adipic acid crosslinking and the like, such as hydroxypropylated tapioca starch, oxidized hydroxypropylated tapioca starch, hydroxypropylated corn starch, and acid-treated hydroxypropylated corn starch . The starch degradation product is obtained by decomposing starch by acid treatment or oxidation treatment, and examples thereof include oxidation-treated waxy corn starch and acid-treated tapioca starch.

  As dextrins, enzyme-modified dextrin produced by enzymatic degradation of starch, white and yellow dextrin produced by acid roasting, British gum obtained by baking under acid-free or alkaline conditions, and There are highly branched cyclic dextrins obtained by using a branching enzyme when enzymatically modifying starch. Of these, enzyme-modified dextrin is widely produced, and those with different DE values are also readily available.

  Other examples of the physically modified starch include starch that has been pregelatinized and heat-moisture treated.

  The plasticizer is at least one selected from the group consisting of sugar alcohols such as glycerin and sorbitol, propylene glycol, polyethylene glycol, glucose, monosaccharides such as fructose, and disaccharides such as trehalose and sucrose. As a compounding quantity of the plasticizer to the soft capsule membrane | film | coat composition of this invention, 10 to 25 weight% is preferable.

  Moreover, the compounding quantity of the water to the soft capsule membrane | film | coat composition of this invention is 30 to 60 weight%, More preferably, it is 35 to 55 weight%.

  Further, the soft capsule film composition of the present invention may optionally include other components such as a pH adjuster such as sodium phosphate, a chelating agent such as trisodium citrate and sodium metaphosphate, and gelation of calcium lactate and potassium chloride. Accelerators, surfactants such as polyglycerin fatty acid esters and lecithin, sweeteners, fragrances, preservatives, colorants and the like can be added as appropriate.

  The solution of the soft capsule film composition of the present invention is a film formed by heating the rotary drum to 30 to 80 ° C. in a process of forming a film sheet by spreading on a rotary drum such as a rotary die type filling machine. Mechanical strength and adhesive force for pressure bonding are added to the sheet, and a soft capsule having sufficient strength can be formed. The contents are sealed with a mold when filling the capsule by heat-sealing two film sheets with segments, or by pressure bonding, or a combination thereof. From the viewpoint of protection from heating in the case of the above, it is desirable that the segment temperature is low. In the present invention, as shown in an example of a later rotary die capsule filling machine, filling and sealing are possible even at room temperature, and it can be sufficiently adapted to such a case.

  EXAMPLES Hereinafter, the present invention will be specifically described with reference to examples, but the present invention is not limited thereto.

(Comparative Examples 1-3 and Examples 1-4)
Based on the formulations shown in Comparative Examples 1 to 3 and Examples 1 to 4 shown in Tables 1 and 2, each component was weighed into a beaker and stirred well, and then stirred well every 15 minutes on a boiling water bath. Dissolve by heating for hours. Thereafter, the mixture is kept at 90 to 95 ° C. for 2 hours to perform a deaeration operation. This solution is put in an applicator for a thin layer chromatograph adjusted to a thickness of 0.6 mm, and spread on a stainless steel plate heated to about 70 ° C. in advance. After gelation, it is cut into an appropriate size, and a soft capsule is formed by a flat plate method using medium-chain fatty acid triglycerides as the contents. In each formulation, the viscosity and operability of the mixed composition when heated and dissolved ( Uniform mixing operability), stickiness and strength of the coated sheet at the time of preparation, adhesiveness of the prepared soft capsule, and blocking when the capsule was dried and stored in a glass bottle was evaluated.

  Comparative Example 1 is an example of a soft capsule film composition in which modified starch and unprocessed starch waxy corn starch are blended as starch, and Comparative Example 2 is a formulation example of modified starch only, both of which contain dextrin in the formulation Absent. As a result, the viscosity is very high and the operability is poor, the coating sheet is somewhat weak, the sheet surface is much sticky, and the adhesiveness of the resulting capsule is also weak. Blocking was also observed. Moreover, in Comparative Example 1, undissolved substances were scattered in the coating sheet, the sheet was non-uniform and the transparency was inferior to the others. Comparative Example 3 is an example in which the proportion of dextrin in the modified starch contained in the capsule film composition is 11.2% and does not reach 20%, but the viscosity is lower than Comparative Examples 1 and 2, but is still high in operability. However, the surface of the coated sheet is somewhat sticky, and the resulting capsule has poor adhesion. Blocking also occurs.

  In contrast, Examples 1 to 3 are soft capsules in which the proportion of dextrin in the modified starch contained in the capsule coating composition was increased between 22.2% and 60.5%, and the viscosity increased as the proportion of dextrin increased. As a result, the operability was improved, the strength of the coated sheet was increased, the stickiness of the sheet surface during preparation was significantly reduced, and the adhesiveness of the capsule was also improved. Furthermore, unlike the comparative example, blocking was also suppressed by the proportion of dextrin exceeding 20% (the dextrin used an enzyme-modified dextrin between DE: 4-7). Example 4 uses DE: 4-9 enzyme-modified dextrin as a dextrin in the modified starch contained in the soft capsule film composition, and the ratio was increased to 92.4%. A transparent and good capsule film and a soft capsule were obtained.

(Comparative Examples 4-5 and Examples 5-6)
Based on the prescriptions of Comparative Examples 4 to 5 and Examples 5 to 6 shown in Table 3, preparation and evaluation of a soft capsule film sheet and a soft capsule were performed in the same manner as in the previous Examples 1 to 4. It was. Here, the ratio of the blended amount of modified starch used in the soft capsule film composition was compared. In Comparative Example 4, since the blending ratio of the modified starch is as small as 15% by weight, the film sheet is weak, the surface of the film sheet is somewhat sticky, and the adhesion of the resulting capsule is also weak. Blocking also occurs. On the other hand, in Example 5 in which the blending ratio of the modified starch was increased to 22% by weight, the sheet strength was increased as compared with Comparative Example 4, the surface tackiness was suppressed, and the capsule adhesion was improved. In Example 6 where the blending ratio of the modified starch was increased to 48% by weight, the viscosity of the coating composition was high and the operability was slightly poor, but other items such as sheet strength were good. However, when the blending ratio of the modified starch exceeds 50% by weight and is further increased to 55% by weight (Comparative Example 5), the viscosity of the soft capsule film composition at the time of dissolution by heating becomes very high, so that a uniform film composition can be obtained. In addition, the sheet was not formed because of low fluidity.

(Comparative Examples 6-7 and Examples 7-8)
Based on the prescriptions of Comparative Examples 6 to 7 and Examples 7 to 8 shown in Table 4, preparation and evaluation of the soft capsule film sheet and soft capsule agent were performed in the same manner as in the previous Examples 1 to 4. It was. Here, the amount of native gellan gum used in the soft capsule film composition was compared and examined. In Comparative Example 6, since the blend amount of native gellan gum is as small as 1.2% by weight, gelation is insufficient and the coating sheet is weak, the coating sheet surface is slightly sticky, and the adhesion of the resulting capsule is slightly weak. Blocking also occurs in some areas. On the other hand, in Example 7 in which the blend amount of the native gellan gum was increased to 1.5% by weight, the sheet strength was increased as compared with Comparative Example 6, the surface stickiness was suppressed, and the capsule adhesiveness was also improved. In Example 8 where the blending amount of native gellan gum was increased to 6% by weight, the viscosity of the coating composition was high and the operability was slightly poor, but other items such as sheet strength and sheet surface tackiness were good. It was. However, when the blending amount of native gellan gum is further increased to 7% by weight (Comparative Example 7), the viscosity of the soft capsule film composition at the time of heating and dissolution becomes very high, and it does not become a uniform film composition, and the fluidity is also high. The sheet was not formed due to the low level.

(Comparative Examples 8-9 and Examples 9-10)
Based on the prescriptions of Comparative Examples 8 to 9 and Examples 9 to 10 shown in Table 5, preparation and evaluation of the soft capsule film sheet and soft capsule agent were performed in the same manner as in the previous Examples 1 to 4. It was. Here, the amount of deacylated gellan gum used in the soft capsule film composition was compared and examined. Comparative Example 8 is a formulation that does not contain deacylated gellan gum, and the film sheet is stretched but slightly shrunk and slightly weak. In addition, other items such as the adhesiveness of the capsule are generally poor as compared with Example 9 containing 0.04% by weight of deacylated gellan gum. On the other hand, in Example 10 in which the amount of the deacylated gellan gum was increased to 3.0% by weight, the total amount of the gelling agent was as high as 6.8% by weight, so that the viscosity of the coating composition was increased and the operability was slightly poor. However, other items such as sheet strength and sheet surface tackiness were satisfactory. However, when the blending amount of deacylated gellan gum is further increased to 3.4% by weight (Comparative Example 9), some undissolved substances are scattered in the sheet together with poor operability during heating and dissolution, and compared with Example 10. The film sheet became slightly brittle.

(Comparative Examples 10-11 and Examples 11-14)
Based on the formulations of Comparative Examples 10 to 11 and Examples 11 to 14 shown in Tables 6 to 7, preparation and evaluation of soft capsule film sheets and soft capsules in the same manner as in the previous Examples 1 to 4 Went. Here, a comparative study was made on the ratio of the blend amounts of native gellan gum and deacylated gellan gum used in the soft capsule film composition. In Tables 6 to 7, the ratio of the blend amount of native gellan gum and deacyl gellan gum is expressed as the deacyl gellan gum ratio: the total blend amount of native gellan gum and deacyl gellan gum in the soft capsule film composition. It was expressed as a percentage of the amount of deacylated gellan gum blended with respect to.

  In Comparative Example 10, since the ratio of the deacylated gellan gum is as low as 0.25%, the film sheet is stretched but the shrinkage is small and slightly weak. Further, the surface of the coating sheet is somewhat sticky, and blocking is also caused in part. On the other hand, in Example 11 in which the ratio of deacylated gellan gum was increased to 1.0% (the ratio of the blend amount of native gellan gum and deacylated gellan gum was 99: 1), the sheet strength and stretchability were higher than those of Comparative Example 10. Rise, surface stickiness and capsule blocking were also improved. Deacyl gellan gum ratio is 3.3% (ratio of native gellan gum and deacyl gellan gum is 30: 1), 33.3% (ratio of native gellan gum and deacyl gellan gum is 2: 1), In Examples 12 to 14 in which 45.7% (ratio of blending amount of native gellan gum and deacylated gellan gum is 10: 9), good soft capsules are obtained. Further, in Comparative Example 11 in which the ratio of deacylated gellan gum was increased to 50.0% (the ratio of the blending amount of native gellan gum to deacylated gellan gum was 10:10), the blended amount of deacylated gellan gum having a hard and brittle property was obtained. The increase resulted in brittleness of the coating sheet, and the adhesion of the capsule was slightly weakened.

(Examples 15 to 17)
Based on the formulations of Examples 15 to 17 shown in Table 8, soft capsule film sheets and soft capsules were prepared and evaluated in the same manner as in the previous Examples 1 to 4. In Examples 15 to 17, the coating strength was further strengthened by mixing the enzyme-modified dextrin with other modified starches such as oxidized waxy corn starch and acid-treated hydroxypropylated corn starch. As a result, a soft capsule with high capsule adhesion was obtained.

(Examples 18 and 19)
In the formulation of Examples 18 and 19 shown in Table 9 (dextrin is an enzyme-modified dextrin of DE: 4 and the proportion of dextrin in the modified starch contained in the capsule coating composition is 63.1%) The soft capsule was stably and continuously filled for 2 hours using a rotary die type capsule filling machine.

  The rotary die type capsule filling machine is shown as a rotary die type capsule filling machine 10 in FIG. 1, and its usage is as follows.

  The rotary die type capsule filling machine 10 spreads the soft capsule film composition solution supplied from the tank 11 on the left and right rotating drums 13 by the left and right casting devices 12 to obtain the left and right film sheets A. The left and right coating sheets A are sent to a cylindrical mold (die roll) 16 that rotates left and right via a lubrication roller 14 and a deflecting roll 15. The left and right coating sheets A are fed between the left and right molds 16 in sliding contact with the wedge-shaped segments 17 disposed on the upper portions of the left and right molds 16, and the piston 18 </ b> A of the pump 18 interlocking with the molds 16. The contents B to be pumped are press-fitted between the left and right coating sheets A that are sandwiched between the left and right molds 16 and meet each other. The left and right coating sheets A are given recesses by the recesses 16A of the left and right molds 16, and are crimped around the recesses by the periphery of the recesses 16A. Immediately before the recesses on the left and right coating sheets A are completely closed, the contents B are pressed into the recesses. After the contents B are pressed into the recesses of the left and right coating sheets A, the recesses are completely closed by the periphery of the recess 16A in the left and right molds 16 to form a capsule C, and the thickness of the left and right molds 16 is increased. The capsule C is punched by cutting.

At the time of producing the capsule of the present invention, the filling machine was operated under the following operating conditions a to c using the medium-chain fatty acid triglyceride as the contents and the rice salad oil as the example 19 as the contents.
a: The rotating drum 13 that generates the coating sheet A (thickness 0.7 mm) is heated to 30 to 80 ° C., more preferably 35 to 70 ° C., and b: the left and right coating sheets A are The segments 17 fed in between were brought to room temperature (28 ° C.) without heating, and c: the left and right molds 16 were encapsulated by pressure bonding without heat sealing the left and right coating sheets A.

The produced soft capsules were evaluated for strength, stickiness of the coated sheet at the time of production, good ball ratio, average hardness, average adhesion thickness, long-term stability, blocking, and the like of the capsules after drying.
Capsule good sphere ratio: A test sample is extracted from a specimen obtained by drying a part (6280 capsules) of continuous production for 2 hours. The ratio of the number of capsules (good spheres) excluding defective spheres (indicating capsules having deformation, skin bubbles, defective sheets, leaking spheres, bubbles, etc.) in the test sample (1200 samples).
Capsule average hardness: A sample (20 specimens) is subjected to force with a Kiya-type hardness meter (manufactured by Fujiwara Seisakusho Co., Ltd.), the force (kg) at the time of rupture is measured, and the average value is calculated.
Capsule average adhesion thickness: Cut perpendicularly to the adhesive surface of the film at the center of the sample (5 specimens), measure the thickness of the adhesive surface of the film, and calculate the average value .
Capsule long-term stability: Evaluated by observing the appearance of capsules (deformation, discoloration, liquid leakage) after storage for 16 weeks in a constant temperature bath at 40 ° C.
Capsule blocking: Capsules were dried and then filled into glass bottles, and the ease of bonding between capsules was evaluated after long-term storage.

  Even in standard rotary die filling as an industrial production method, the viscosity of the coating composition is low and the operability (uniform mixing operability) is also good, due to the adhesion of the coating sheet to the die roll during production, due to low sheet strength There were no problems such as sheet cutting, and continuous filling of soft capsules was achieved. The obtained soft capsules in Example 18 had an average hardness of 15.1 kg and an average adhesion thickness of 0.35 mm, and in Example 19, the average hardness of 15.4 kg and the average adhesion thickness of 0.36 mm. In addition, it was a high-quality soft capsule with reduced blocking.

FIG. 1 is a schematic view showing a rotary die type capsule filling machine.

Explanation of symbols

10 Rotary Die Type Capsule Filling Machine 13 Rotary Drum 16 Mold 17 Segment

Claims (8)

  A soft capsule coating composition comprising modified starch, native gellan gum, deacylated gellan gum, a plasticizer and water.   The soft capsule coating composition according to claim 1, wherein the modified starch is at least one selected from the group consisting of starch derivatives, starch degradation products, dextrin, and physically modified starch.   The soft capsule film composition according to claim 1 or 2, wherein the dextrin is at least one selected from the group consisting of enzyme-modified dextrin, white dextrin, yellow dextrin, British gum, and highly branched cyclic dextrin.   The soft capsule coating composition according to any one of claims 1 to 3, wherein the amount of the modified starch is 20 to 50% by weight in the coating solution stage before drying.   The soft capsule film composition according to any one of claims 1 to 4, wherein at least 20% or more of the blended amount of the modified starch is dextrin.   The amount of native gellan gum is 1.5 to 6% by weight and the amount of deacylated gellan gum is 0.04 to 3% by weight in the coating solution stage before drying. At that time, the amount of native gellan gum and deacylated gellan gum is mixed. The soft capsule film composition according to any one of claims 1 to 5, wherein the ratio is from 10: 9 to 99: 1.   The soft capsule film composition according to any one of claims 1 to 6, wherein the plasticizer is at least one selected from the group consisting of glycerin, sugar alcohol, propylene glycol, polyethylene glycol, monosaccharide and disaccharide.   In the step of forming a coating sheet by spreading the coating composition solution according to any one of claims 1 to 7 on a rotating drum, the rotating drum is heated to 30 to 80 ° C to form a coating sheet. A soft capsule manufacturing method that adds mechanical strength and adhesive strength for pressure bonding.

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