JP5069417B2 - Film coating layer, film coating product and manufacturing method thereof - Google Patents

Description

  The present invention relates to a hydroxyalkylated dextrin derived from waxy corn starch, a sugar alcohol composition having a maltitol content of 15.0 wt% or more and 99.0 wt% or less in terms of solids, and an HLB value of 11 to 14 The present invention relates to a film coating layer mainly composed of three components of glycerin fatty acid ester, a film coating product in which a core material is coated with the film coating layer, and a method for producing the same.

  Film coating is one of the coating processes that form a thin film-like material on the surface of core material or uncoated tablet to be coated. Depending on the material used for coating, the core material or uncoated tablet is used. It is carried out for various purposes such as smoothing the surface, imparting water resistance, preventing chipping and maintaining the shape.

  For example, in the manufacture of sugar-coated products that use confectionery, food materials, pharmaceuticals, etc. as the core material, film coating may be applied to smooth the periphery of the core material in order to finish the sugar-coated part beautifully. . In addition, in the manufacture of sugar-coated products, aqueous solutions containing sugars and sugar alcohols called sugar-coating liquids are used. For the purpose of reducing the influence of moisture contained in this sugar-coating liquid on the core material and uncoated tablets, A coating process may be applied.

  The sugar coating pointed out above is sometimes called sugar coating when sugar is the main ingredient, and sugarless coating when sugar alcohols are the main ingredient. Sometimes it is called a hard sugar coat or a hard sugar coat with crunchiness such as crunchy or crispy, or a soft sugar coat or a soft sugar coat that provides a soft and soft chewing feeling, but all these meanings are included.

  Film coating is often used as a pre-treatment for sugar coating, but in recent years, the physical properties of film coating itself have begun to improve. The number of people adopting them is increasing. Specifically, in addition to a method using corn protein or shellac as a filming agent, as a material or manufacturing technology applicable to a new film coating, a yeast cell wall or hydroxypropylmethylcellulose is used as a filming agent. 1 and Patent Document 2 have been proposed.

  For example, Patent Literature 1 discloses granular hydroxypropylmethylcellulose and / or methylcellulose having an average particle size of 200 to 1000 μm, and a concentration of particles having a particle size of 75 μm or less is 5 to 5% with respect to the coating base. A fast-dissolving coating composition comprising 30% by weight of a liquid plasticizer at normal temperature and 1 to 30% by weight of a pigment is disclosed as a fast-dissolving coating composition that becomes a film. .

  Further, Patent Document 2 is formed from a coating agent characterized by comprising a yeast cell wall fraction consisting of a cell residue obtained by removing soluble intracellular components from enzyme-treated yeast, and the coating agent. A coating film is disclosed.

JP-A-9-59147 JP 2000-44878 A

  However, many of the materials that form conventional film coatings are difficult to handle due to their high viscosity when handling a coating solution in which components necessary for film coating formation are dissolved. There is a problem that it takes time to form the film.

  In addition, some of the materials that form film coatings are originally colored, and those that are easily colored brown, dark, brown, etc. during the manufacturing process. There are problems such as lack of color and difficulty in desired coloring of the film coating layer. Further, with respect to the gloss of the surface of the film coating layer, what is obtained with conventional materials is not always sufficient, and further improvements are required.

  In addition, since conventional film coatings may use materials that are insoluble or sparingly soluble in water, the disintegration property of film-coated products is not preferable. In addition, an unpleasant residual feeling is given and an ingestion feeling is undesirable. Therefore, development of a film coating product having excellent disintegration is also demanded.

  The problem to be solved by the present invention is that the surface of the formed film coating layer is glossy, has no cracks, has an excellent gloss, and has less unnecessary coloring derived from the raw material of the film coating layer. Developed new film coating layers, film coating products, and production methods that have the characteristics of easy coloration, excellent disintegration when used as film coating products, and short time required to produce film coating products. There is to do.

  As a result of earnestly examining the solution of the above problems, the present inventor has, as a main component for forming a film coating layer, a hydroxyalkylated dextrin derived from waxy corn starch and a maltitol content of 15.0% by weight or more in terms of solid matter. By using a combination of 3 components of a sugar alcohol composition of 99.0% by weight or less and a glycerin fatty acid ester having an HLB value of 11 to 14, this problem is improved or solved and the present invention is completed. It was.

  That is, the means for solving the problems of the present invention are as follows.

  First, a hydroxyalkylated dextrin derived from waxy corn starch, a sugar alcohol composition having a maltitol content of 15.0 wt% or more and 99.0 wt% or less in terms of solid, and an HLB value of 11 to 14 It is the film coating layer which has as a main component three components of glycerol fatty acid ester which is.

  Second, the content in terms of solids is 70.0 to 95.0% by weight of hydroxyalkylated dextrin, 3.0 to 28.0% by weight of sugar alcohol composition, and 0.1% of glycerin fatty acid ester. It is a film coating layer as described in 1st which is -10.0 weight%.

  Third, the film coating layer according to the first or second aspect, wherein the hydroxyalkylated dextrin is hydroxypropylated dextrin.

  Fourth, the dextrose equivalent (DE) of the hydroxyalkylated dextrin is 0.1 to less than 5.0, and the film coating layer according to any one of the first to third.

  Fifth, the film coating layer according to any one of the first to fourth, wherein the hydroxyalkylated dextrin is crosslinked by a crosslinking agent.

  Sixth, when the hydroxyalkylated dextrin is an aqueous solution having a solid content of 30% by weight and a temperature of 30 ° C., the viscosity of the aqueous solution is 50 to 350 cp, according to any one of the first to fifth items. It is a film coating layer.

  Seventh, when the sugar alcohol composition is an aqueous solution having a solid content concentration of 70% by weight and a temperature of 25 ° C., the viscosity of the aqueous solution is 150 to 1500 cp, according to any one of the first to sixth items. It is a film coating layer.

  Eighth, it is a film coating product in which the core is coated with the film coating layer described in any one of the first to seventh.

  Ninth, the content in terms of solids is 70.0-95.0% by weight of hydroxyalkylated dextrin derived from waxy corn starch, and the maltitol content is 15.0% by weight or more in terms of solids 99.0%. The coating solution prepared by preparing a coating solution in which the sugar alcohol composition is 3.0 to 28.0% by weight and the glycerin fatty acid ester is 0.1 to 10.0% by weight. Applying the solution to the core material to be coated with the film coating layer and drying the coating solution applied around the core material until a desired film coating layer is formed, This is a method for producing a film-coated product.

  In the present invention, the coating solution refers to an aqueous solution containing raw materials necessary for forming a film coating layer. In addition, the film coating layer is a method in which a solid component in the coating solution is solidified by applying the coating solution around the core material and drying the applied coating solution, and applying and drying these coating solutions are desired. The solidified product covering the core material in the form of a thin layer, obtained by continuing until the solidified material having a thickness or weight of 1 is formed around the core material. The film coating layer is transparent because it solidifies from the coating solution into an amorphous state, and has a smooth and glossy surface. This is different from hard sugar coating and soft sugar coating formed by crystallization of sugars and sugar alcohols.

  In the film coating layer according to the present invention, hydroxyalkylated dextrin is employed as the first component.

  In preparing the hydroxyalkylated dextrin, the starch is hydroxyalkylated and then hydrolyzed by a known method until it has a desired dextrose equivallent (DE); Any method of preparing a dextrin having DE and then performing a hydroxyalkylation treatment on the obtained dextrin may be adopted. However, considering the ease of preparation and the stability of quality after preparation, it can be said that the former preparation method in which starch is hydroxyalkylated first is preferable.

  The starch hydrolysis treatment performed in the preparation of the hydroxyalkylated dextrin is not particularly limited as long as the starch is hydrolyzed to a desired DE value, such as acid, alkali, heat treatment, and enzyme treatment. Since preparation of dextrin having DE is easy, hydrolysis treatment by enzyme treatment typified by α-amylase is preferable. The DE of the dextrin part of the hydroxyalkylated dextrin varies depending on the substitution degree of hydroxyalkylation and the presence or absence of crosslinking, but the approximate DE is 0.1 or more and less than 5.0, preferably 0.5 or more and 3. It is 5 or less, Especially preferably, they are 1.0 or more and 2.5 or less, Most preferably, they are 1.2 or more and 2.0 or less.

  In the preparation of hydroxyalkylated dextrins, as described above, dextrins can also be prepared by hydrolyzing starch until it has the desired DE using acid. On the other hand, there is a substance called acid-treated starch by those skilled in the art in Japan. This is a substance sometimes translated as Thinboiling Starch and Modified Starch, and it is listed as a kind of modified starch as a classification, but as the name suggests, it is one of the substances obtained by treating starch with mineral acid solution. Therefore, confusion with dextrin that can be prepared by acid hydrolysis may occur. However, acid-treated starch and dextrin have differences not only in classification but also in terms of substances and physical properties. For example, the former acid-treated starch is a part of the amorphous part of starch particles. Is decomposed, but the starch particle structure itself remains, and a color reaction that turns purple with respect to the iodine starch reaction is observed. Moreover, since the starch structure substantially remains in the acid-treated starch, it is very difficult to define the degree of decomposition by DE. On the other hand, the latter dextrin does not retain the starch particle structure and has a degree of decomposition that can be defined by DE. Therefore, in the present invention, the hydroxyalkylated dextrin employed in the present invention and the substance called acid-treated hydroxyalkylated starch or hydroxyalkylated acid-treated starch are treated as completely different substances.

  For the hydroxyalkylated dextrin employed in the present invention, only waxy corn starch is employed as the raw material starch used for the preparation. Various starches other than waxy corn starch, such as high amylose corn starch, wheat starch, rice starch, sago starch, potato starch, sweet potato starch, tapioca starch, etc. It is difficult to form a preferred film coating product.

  Hydroxyalkylated dextrin is obtained by performing hydroxyalkylation by acting various alkylene oxides such as ethylene oxide, propylene oxide, butylene oxide, etc. on the raw material waxy corn starch or dextrin derived from waxy corn starch . Among these, hydroxypropylated dextrin is preferable because of the favorable quality when it is used as a film coating layer. The degree of substitution representing the degree of hydroxyalkylation may be slightly varied depending on the presence or absence of crosslinking treatment, the DE value of dextrin, and the like, but there is no particular limitation as long as the implementation of the present invention is not hindered. The degree of substitution is a value obtained from the average value of substituents per glucose residue of starch, and the degree of substitution may be expressed as DS (degree of substitution). Illustrative examples of the degree of substitution preferred in the present invention are DS of about 0.01 to 0.36, and a more preferred range is DS of 0.03 to 0.20, and among them, particularly preferred is DS of about 0.06 to 0.18. . In the present invention, there is no need to increase the degree of substitution more than necessary, but there is no particular problem even if the degree of substitution is increased beyond the numerical values shown above.

  Hydroxyalkylated dextrin is a hydroxyalkylated cross-linked dextrin that has been reacted with a cross-linking agent to give a cross-linked structure, thereby suppressing aging of the dextrin part, and as a result, preventing white turbidity when used as a coating solution, and coating It is possible to suppress the increase in viscosity of the solution over time. Moreover, since it is stable over time, it is possible to make a coating solution, and a favorable effect can be brought about when it is carried out on an industrial scale. Cross-linking agents include epichlorohydrin, sodium trimetaphosphate, sodium trimetaphosphate / sodium tripolyphosphate, acrolein, cyanuric chloride, adipic acid / acetic acid mixed anhydride, phosphorus oxychloride, formalin, diepoxide compound, dialdehyde Any reagent that can react with the hydroxyl group of starch to form a crosslinked structure, such as a compound, can be used. Of the cross-linked structures obtained by the cross-linking agent, it can be said that hydroxyalkylated phosphoric acid cross-linked dextrin that is phosphoric acid-cross-linked is particularly preferable.

  There is no particular limitation on the timing of the crosslinking reaction in the preparation of the hydroxyalkylated crosslinked dextrin. For example, the starch or dextrin before the hydroxyalkylation reaction is subjected to a crosslinking reaction, and once the crosslinked starch or crosslinked dextrin is formed, the hydroxyalkylation is performed, and finally the desired DE is obtained as necessary. You may employ | adopt the preparation method which performs a hydrolysis process until it has. As another method, it is also possible to employ a preparation method in which a starch or dextrin is subjected to a hydroxyalkylation reaction to obtain a hydroxyalkylated starch or a hydroxyalkylated dextrin, and then a crosslinking reaction is performed. And finally, you may employ | adopt the preparation method which performs a hydrolysis process until it has desired DE as needed. Moreover, when performing these reactions, there is no restriction | limiting in particular about the grade of a crosslinking reaction, if it is a range which does not prevent implementation of this invention. In the present invention, starch is used as a starting material, hydroxyalkylated starch is then prepared by a hydroxyalkylation treatment, then a hydroxyalkylated crosslinked starch having a crosslinked structure is prepared by a crosslinking agent, and finally a desired DE is obtained. A preparation method in which the hydrolysis reaction is carried out until it has a hydroxyalkylated cross-linked dextrin is preferred in terms of easy control of the preparation reaction and stability of quality.

  As a preferred raw material form of the film coating layer according to the present invention, hydroxypropylated starch having waxy corn starch as a starting material and having a substitution degree of 0.01 or more, preferably a substitution degree of about 0.06 to 0.18 by hydroxypropylation And then having a DE of 0.1 or more and less than 5.0, preferably about 1.2 to about DE 2.0 by enzymatic hydrolysis. Propylated phosphate cross-linked dextrin can be exemplified.

  Hydroxyalkylated dextrin can be prepared in various physical properties depending on various factors such as the type of hydroxyalkyl group and the degree of substitution thereof, the presence or absence of a crosslinking agent, and the DE value of the dextrin part. As an index for suitably expressing, an aqueous solution of hydroxyalkylated dextrin can be prepared and evaluated by the viscosity of the aqueous solution at that time. Specifically, an aqueous hydroxyalkylated dextrin solution having a solid content of 30% by weight and a temperature of 30 ° C. is prepared, and the standard of the lower limit when the viscosity at that time is measured with a B-type viscometer is preferably 50 cp or more, More preferably, it is 100 cp or more, Especially preferably, it is 140 cp or more, Most preferably, it is 150 cp or more. The upper limit of the viscosity range is preferably 350 cp or less, more preferably 320 cp or less, particularly preferably 300 cp or less, and most preferably 270 cp or less. By adopting a hydroxyalkylated dextrin having the above-mentioned viscosity when it is used as an aqueous solution, a preferable effect according to the present invention can be brought about.

  In the film coating layer according to the present invention, a sugar alcohol composition containing maltitol in a predetermined ratio as the second component is employed. Specifically, the sugar alcohol composition has a maltitol content in the sugar alcohol composition of 15.0 wt% or more and 99.0 wt% or less in terms of solid matter. A preferred form of the sugar alcohol composition is a sugar alcohol composition containing maltitol as a main component and having a maltitol content of not less than 50.0% by weight and not more than 99.0% by weight in terms of solid matter. . Of the sugar alcohol compositions containing maltitol as a main component, a sugar alcohol composition having a maltitol content of 60.0 wt% or more and 99.0 wt% or less in terms of solid matter is preferable. Among them, a sugar alcohol composition having a maltitol content of 70.0 wt% or more and 99.0 wt% or less in terms of solid matter is more preferable. Among them, a sugar alcohol composition having a maltitol content of 80.0 wt% or more and 99.0 wt% or less in terms of solid matter is particularly preferable. Among them, a sugar alcohol composition having a maltitol content of 90.0% by weight or more and less than 98.0% by weight in terms of solid matter is most preferable.

  In the sugar alcohol composition according to the present invention, as a remaining component excluding maltitol, sugar alcohols other than maltitol may be contained in an amount of 1.0% by weight to 85.0% by weight in terms of solid matter. Required. In the sugar alcohol composition according to the present invention, it is needless to say that the preferable content ratio of sugar alcohols other than maltitol is appropriately changed according to the above-mentioned preferable maltitol content. That is, in the sugar alcohol composition according to the present invention, the preferred content of sugar alcohols other than maltitol is 1.0% by weight or more and 50.0% by weight or less in terms of solids, more preferably solids. 1.0 wt% or more and 40.0 wt% or less in terms of product, more preferably 1.0 wt% or more and 30.0 wt% or less in terms of solid matter, and particularly preferably among them It is 1.0 wt% or more and 20.0 wt% or less in terms of conversion, and most preferably the content is 2.0 wt% or more and 10.0 wt% or less in terms of solid matter.

  Examples of substances that can be employed as sugar alcohols other than maltitol in the sugar alcohol composition according to the present invention include sorbitol, mannitol, erythritol, xylitol, lactitol, palatinit (registered trademark), ribitol, arabitol, cellobiitol, Maltitol, maltotriitol, maltoteitol, and other reduced maltooligosaccharides for each degree of polymerization, reduced dextrin, xylobiitol, xylobitriitol, xylotetriitol, and other reduced xylooligosaccharides for each degree of polymerization, mannobiitol, Examples thereof include mannotriitol, mannotetriitol, other reduced manno-oligosaccharides according to the degree of polymerization, and one or a mixture of two or more selected from the above group.

  As a preferred form of the sugar alcohol composition according to the present invention, a reduced starch hydrolyzed substance containing 15.0 wt% or more and 99.0 wt% or less maltitol in terms of solid matter, which is a substance prepared from a starch raw material. Examples include decomposed products, reduced maltose starch syrup, maltitol honey crystals, and one or a mixture of two or more selected from the above group. The reduced starch hydrolyzate is synonymous with substances called reduced starch saccharified product and reduced starch syrup, and includes these substances. Of these, maltitol-containing crystals are most preferred. In addition, as long as the maltitol content in terms of solid matter has a maltitol purity comparable to that of maltitol-containing crystals, any powdered product or liquid product can be used.

  When crystalline maltitol having a purity of more than 99.0% by weight alone is used in place of the sugar alcohol composition according to the present invention, the film coating layer cannot be provided with sufficient plasticity by itself. It is not preferable because it can cause cracking in the film coating layer. However, a sugar having a maltitol content in a range not impeding the practice of the present invention by mixing with sugar alcohols other than the above-mentioned maltitol, reduced starch hydrolyzate, reduced maltose starch syrup, maltitol honey crystal, etc. If prepared into an alcohol composition, there is no problem in using crystalline maltitol having a purity exceeding 99.0% by weight.

  In the sugar alcohol composition according to the present invention, as described above, the maltitol content in the sugar alcohol composition is a very important factor, but it is also important to have a certain range of viscosity. Specifically, when the sugar alcohol composition is an aqueous solution having a solid concentration of 70% by weight and the liquid temperature is 25 ° C., the measured value by a B-type viscometer is 150 to 1500 cp, preferably 160 to 1200 cp. More preferably 170 to 600 cp, and particularly preferably 250 to 400 cp. By adopting a sugar alcohol composition that satisfies the above-mentioned viscosity range, the surface of the obtained film coating layer is easy to finish smoothly, the film coating layer after production is difficult to crack, and the film coating layer in the production process is difficult to crack. Preferred effects such as little peeling and the ability to produce a film-coated product in a short time are obtained.

  When a sugar alcohol composition having a viscosity outside the above-described viscosity range is employed, it is considered that the binding property of the coating solution is not sufficient, but the coating solution does not sufficiently adhere around the core material to be coated. The film coating layer is likely to be peeled off during the production process, and the surface of the formed film coating layer is liable to crack. In addition, when a sugar alcohol composition having a high viscosity outside the above-mentioned viscosity range is adopted, it is considered that the binding property of the coating solution is too strong, but the film coating layer in the forming process does not adhere to the coating solution. During repeated binding and detachment with the surrounding core material, the formed film coating layer may be peeled off, or a large amount of core material binding may occur, causing the core material to be lumpy This is not preferable because it may solidify.

  For the sugar alcohol composition according to the present invention, sugar alcohol products marketed as reduced starch hydrolysates or maltitol-containing crystals can be employed as they are. For example, sugars sold under the names of “AMAMIR”, “PO-30”, “PO-40”, “PO-60”, “Amalty Syrup” and “Amalty MR” manufactured by Towa Kasei Kogyo Co., Ltd. Alcohol products, sugar alcohol products sold under the names “SE20”, “SE30”, “SE57”, “SE600” and “Sweet G2” manufactured by Nikken Kasei Co., Ltd., Hayashibara Shoji Co., Ltd. "HS-30", "HS-40", "HS-60", and sugar alcohol products sold under the names of "Powder Mabit", manufactured by Celestor, "C ☆ Maltdex" series Sugar alcohol products sold under the names “16303”, “16311”, “16322”, “16330”, “LYCASIN” manufactured by Rocket Freiler “BC”, “LYCASIN 80/55”, “POLYSORB 75/08/55”, “MALTISORB 75/77”, “FD-300” sugar alcohol products sold by Ueno Pharmaceutical Co., Ltd. Examples include products of various companies such as sugar alcohol products sold under the names “MU-65”, “MU-75”, and “MU-90”. Of course, among the above, sugar alcohol products that satisfy the requirements described in the row numbers 0035 to 0040 under higher conditions are more preferable. Specific examples of more preferable products include “Amarty MR” manufactured by Towa Kasei Kogyo Co., Ltd., “Powder Mabit” manufactured by Hayashibara Shoji Co., Ltd., “FD-300” manufactured by Rocket Flaire Co., Ltd., and Ueno Pharmaceutical Co., Ltd. Examples include “MU-90” and other maltitol-containing crystal-type products sold by each company. Among these maltitol-containing honey crystal products, “Amarty MR” manufactured by Towa Kasei Kogyo Co., Ltd. and “Powder Mabit” manufactured by Hayashibara Shoji Co., Ltd., which have a high maltitol content, are examples of highly preferred sugar alcohol compositions. it can.

  The sugar alcohol composition according to the present invention may have a quality that is commercially available for various uses such as foods, food additives, and pharmaceuticals, such as the above-described sugar alcohols. Not particularly affected. Unless the implementation of the present invention is impeded, the above saccharides and sugar alcohols may be liquid products, solid products, slurry products, semi-solidified products, crystal products, honey crystal products, and amorphous powders. It may be either water-containing crystals or anhydrous crystals.

  In the film coating layer which concerns on this invention, the glycerol fatty acid ester whose HLB value is 11-14 is employ | adopted as a 3rd component. More preferably, a glycerin fatty acid ester having an HLB value of 12 or more, particularly preferably an HLB value of 13 or more is employed.

  The type of fatty acid employed in the glycerin fatty acid ester is not particularly limited as long as it does not impede the practice of the present invention, but stearic acid, oleic acid, lauric acid and the like can be exemplified as preferred fatty acids, more preferably stearic acid, oleic acid Most preferably, stearic acid can be exemplified.

  In the present invention, a hydroxyalkylated dextrin derived from waxy corn starch, a sugar alcohol composition having a maltitol content of 15.0 wt% or more and 99.0 wt% or less in terms of solids, and an HLB value of 11 to 14 Although glycerin fatty acid ester and the above three components are the main components, various additives may be used as long as the formation of the film coating layer is not hindered.

  As long as the implementation of the present invention is not hindered, as an additive of the film coating layer, hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose, pullulan, water-soluble pullulan derivative, gelatin, gum arabic, starch, karaya gum, xanthan gum, ethylcellulose, Various bases such as hydroxyethyl cellulose, carboxymethyl cellulose, oxidized starch, acid-treated starch, hydroxypropylated starch, talc, kaolin, calcium carbonate, eggshell calcium, and shell calcium may be used alone or in combination.

  As long as the implementation of the present invention is not hindered, as an additive of the film coating layer, various flavors such as mint flavor, various fruit flavors, chocolate flavor, coffee flavor, tea flavor, vanilla flavor, glycine, alanine, valine, Various amino acids such as leucine, tyrosine, isoleucine, arginine, glutamine, lysine, aspartic acid, glutamic acid, proline, cysteine, threonine, methionine, histidine, phenylalanine, tryptophan, asparagine, serine, citric acid, malic acid, succinic acid, lactic acid, Glycoic acid, tartaric acid, acetic acid, acetic anhydride, adipic acid, maleic acid, fumaric acid, ascorbic acid, alginic acid, gluconic acid, nicotinic acid and other organic acids and their salts, aspartame Examples include various high-intensity sweeteners such as sucralose, acesulfame K, stevia, various colorants such as titanium dioxide and food coloring, vitamins, dietary fibers, etc., and these may be used alone or in combination of two or more. Also good.

  In the present invention, the content of the hydroxyalkylated dextrin which is the first component constituting the film coating layer is 70.0 to 95.0% by weight, preferably in terms of the weight of the solid substance constituting the film coating layer. Is 75.0-90.0 wt%, more preferably 76.0-88.0 wt%, most preferably 81.0-83.0 wt%.

  In the present invention, the content of the sugar alcohol composition in which the maltitol content, which is the second component constituting the film coating layer, is 15.0 wt% or more and 99.0 wt% or less in terms of solids is film coating In terms of the weight of the solid material constituting the layer, 3.0 to 28.0 wt%, preferably 9.0 to 22.0 wt%, more preferably 10.0 to 21.0 wt%, most preferably 15.0 to 17.0% by weight.

  In the present invention, the content of the glycerin fatty acid ester having an HLB value of 11 to 14, which is the third component constituting the film coating layer, is 0.1 to 0.1 in terms of the solid substance weight constituting the film coating layer. 10.0% by weight, preferably 0.5 to 7.0% by weight, more preferably 1.0 to 5.0% by weight, and most preferably 2.0 to 3.0% by weight.

  When the content of each component constituting the film coating layer is out of the above range, cracks on the surface of the film coating layer, loss of gloss, delay in the formation of the film coating layer, and the film coating layer is removed from the core during production. Undesirable influences such as peeling may occur.

  The material applicable as the core material of the film coating product according to the present invention is not limited as long as it is not a material that significantly hinders the formation of the film coating layer, and any material that is known to be used as the core material of the coating product. The present invention can also be applied. Specific core materials include, for example, gum, candy, troches, tablets, gummi, chocolate, jelly, bread, cakes, pretzels, crackers, toffee, dumplings, fried confectionery, snack confectionery, potato chips, sweet natto, and popcorn. , Various fruits, various vegetables, various beans and their dry matter, and other medicines can be used as a core material, and the shape is not particularly limited. In addition, in the fields other than food and pharmaceuticals such as electrical products, conductive wires, vinyl products, plastic products, metal products, circuit boards, semiconductors, containers, porcelain, ceramics, etc. It can be a core material according to the invention.

  In the production of the film coating layer or film coating product according to the present invention, the core material continues to move or rotate in an arbitrary direction during the formation process, and the coating solution is applied to the core material continuously or intermittently in that state. In parallel with this, the core material is continuously dried and the coating solution is applied and dried continuously until a film coating layer having a desired thickness or weight is formed. Can be mentioned. Preferably, the coating solution is applied and dried simultaneously and continuously, and more preferably, the coating solution application and drying conditions are set so that the drying proceeds preferentially under the conditions, and the core material is desired. The method of carrying out continuously until a film coating layer having a thickness or weight of 5 mm is formed.

  In manufacturing the film coating layer and the film coating product according to the present invention, as an apparatus capable of suitably carrying out the above-mentioned processes, a fully automatic coating machine (device name: High Coater Lab / HC-LABO, Freund Industries) Manufactured by the same company). In the present invention, any apparatus having substantially the same performance as the above-described apparatus can be employed as long as the implementation of the present invention is not hindered. In addition, even if the apparatus does not have the same performance as the above-described apparatus, the implementation of the present invention is hindered if the apparatus has a performance according to the above-described apparatus or an apparatus that can substantially manufacture a film coating. As long as there is no such thing, those apparatuses are also employable.

  When the above-mentioned fully automatic coating machine is used in the preparation of a film coating product, the coating material is applied to the core material to be film-coated while rotating in an arbitrary direction in the apparatus. The coating solution adheres. In addition, since the coating solution is continuously dried in parallel with the application of the coating solution, the coating solution that uniformly adheres around the core material starts to solidify in a relatively short period of time, and the adhered coating solution is solidified. Is uniformly formed around the core material. Thereafter, the coating and drying of these coating solutions are continuously performed until a film coating layer having a desired thickness or weight is formed, whereby a film coating product can be prepared.

  In the present invention, the application of the coating solution is not particularly limited as long as it does not interfere with the implementation of the present invention as long as the coating solution is applied to the surface of the core material or the periphery thereof or is performed so as to come into contact. , Spraying, spraying, dipping, dipping, or any other means or method expressed in a substantially equivalent sense.

  When preparing a film coating product, the solid content concentration of the coating solution is determined by a combination of a coating solution application process performed continuously or intermittently on the core material and a drying process performed continuously. Any condition may be used as long as a film coating layer having a desired quality can be obtained. The preferable solid content concentration of the coating solution that can be employed in the present invention is 5 to 30% by weight, more preferably 10 to 25% by weight, and particularly preferably 14 to 23% by weight, and most preferably 15 to 17% by weight.

  Conventionally, in the formation of a film coating layer, the solid concentration of a coating solution generally employed by those skilled in the art when a water-insoluble component such as shellac is not added is about 8 to 10% by weight. The coating solution employed in the present invention has a high solid content concentration of 10% by weight or more, preferably 14% by weight or more, and more preferably 15% by weight or more, despite the condition that no water-insoluble component is added. The coating solution is also characterized in that the formation of the coating layer can be suitably carried out, for example, the core material becomes lumpy in the process of forming the film coating layer, and the formed film coating layer hardly peels off. This is because the coating solution employed in the present invention has an appropriate viscosity and solidifying property that hardly inhibits the formation of a film coating, despite having a high film property.

  In the present invention, the term “coating layer coverage” is adopted as an index representing the amount of the film coating layer formed. The coating layer coverage is the solid content weight ratio of the film coating layer formed with respect to the solid content weight of the core material as 100%. This is synonymous with the value obtained by dividing the solid content weight of the formed film coating layer by the solid content weight of the core material. The term “coating layer coverage” is sometimes called “coating rate” by those skilled in the art, and is used as an index indicating the thickness of the coating layer and the degree of coating. As a method of measuring the weight of the film coating layer, the formed film coating layer may be separated from the core material, and the weight of the part may be directly measured. However, the weight of the core material before coating is determined from the weight of the film coating product. The value obtained by subtracting may be used as the weight of the film coating layer, and the coating layer coverage may be obtained based on the value.

  In the film coating product according to the present invention, it is sufficient that the core material is coated with a significant amount by the film coating layer. When the coating layer coverage is 0.1% or more, formation of the film coating layer is recognized. In the present invention, the upper limit of the coating layer coverage is not particularly limited. For example, the present invention can be implemented even when the coating layer coverage is 100%. However, even if the coating layer coverage is increased more than necessary, there is no significant improvement in the obtained effect, the manufacturing time is long, and it is not economical. Therefore, the coating layer coverage used in the present invention is 0.1% or more, preferably 0.5 to 30.0%, more preferably 1.0 to 10.0%, and particularly preferably 2 among them. 0.0-5.0%, most preferably about 3.0%.

  The present invention is characterized in that it takes less time to form a desired film coating layer on the core material. Specifically, a commercially available lactose simulated tablet (tablet diameter: 10 mm, R: 8.5 mm, H: 1.63 mm, average weight: 360 mg / tablet, manufactured by Sankei Health Co., Ltd.) is used as a core material, and the coating layer coverage is When the film coating layer is formed under conditions favorable for formation in a short period of time in producing a film coating product having a content of 3%, the time required for the formation is 40 minutes or less, preferably 38 minutes or less. Further, the production is possible in a short time of 33 minutes or less, particularly preferably 31 minutes or less, and most preferably 30 minutes or less.

  The film coating product according to the present invention is glossy on the surface of the formed film coating layer, has no cracks, has an excellent luster, and has little unnecessary coloration derived from the raw material of the film coating layer. It has the characteristics that the coloring derived from the agent and coloring with little deviation are possible. Furthermore, it has the characteristics that it is excellent in disintegration when it is used as a film coating product, and the time required for manufacturing the film coating product is short.

  Preferred features derived from the film-coated product according to the present invention are lactose simulated tablets (tablet diameter: 10 mm, R: 8.5 mm, H: 1.63 mm, average weight: 360 mg / tablet, manufactured by Sankei Health Co., Ltd.) ), Coating is performed until the average weight of the film-coated product is 371 mg / tablet, and a film-coated product having an average coating layer coverage of 3% is prepared, and then an aluminum storage bag with a zipper (Product name: Rami Zip AL16, manufactured by Nippon Nihon Co., Ltd.) Sealed and allowed to stand at room temperature for 24 hours as a sample, and evaluated by various evaluation tests, it is evaluated as follows. It has an effect.

  The film coating product according to the present invention has a very smooth finish on the surface of the film coating layer, and almost no cracks are observed in the formed film coating layer. This seems to be because the solidified state is stably maintained by the interaction of the solidifying components forming the film coating layer. In the present invention, in order to confirm the few cracks on the surface of the film coating layer, 20 samples are arbitrarily taken out from the prepared film coating product, and stored in a desiccator with a relative humidity of 9% for 1 month at room temperature. When the presence or absence of cracks on the surface of the film coating layer was confirmed, it was confirmed that no cracks were generated in the product of the present invention. That is, it can be confirmed that the film coating product according to the present invention shows a very excellent result that the ratio of occurrence of cracks in the surface film coating layer is less than 1 sample per 20 samples.

  In the present invention, the formed film coating layer is smooth, and a glossy film coating product can be obtained. In the present invention, a gloss meter (device name: GLOSS METER VG-2000, manufactured by Nippon Denshoku Industries Co., Ltd.) was used as a method for evaluating the gloss of the film coating product. In the glossiness measurement using the gloss meter, a special sample table (device name: φ6 attachment) with a 6 mm circular hole formed in the center of the device is used, and the incidence is made by a 75-degree specular gloss method. The measurement was performed under the conditions of an angle of 75 ° and a light receiving angle of 75 °. The glossiness of 5 specimens per product was measured, and the average value was taken as the glossiness of the product. As a result, in the present invention, the glossiness is evaluated to be 10.0 or higher, preferably 12.0 or higher, more preferably 14.0 or higher, particularly preferably 15.0 or higher, and most preferably 16.0 or higher. It can be confirmed that the film coating product has a high gloss.

  In the present invention, since the formed film coating layer is smooth, free of cracks, and has high gloss, it can be confirmed that the film coating product finally obtained has a favorable gloss when visually confirmed.

  In the present invention, since the raw material used for forming the film coating layer is colorless and has high chemical stability, almost no coloration is seen in the formation process of the film coating layer, and the formation of a substantially colorless and transparent film coating layer is possible. Is possible. Therefore, when a film coating product is prepared by adding a colorant to the coating solution, it is possible to form a film coating product having a bright color. Here, with regard to coloring when it is used as a film coating product, a glossy version of a standard color chart compliant with JIS-Z-8721 by a trained panelist (issued by the Japanese Standards Association, produced by the Japan Color Research Institute) The product of the present invention has a high brightness (V) and saturation (C) at a specific hue (H). Specifically, when a yellow colorant is used under the conditions described in the examples according to the present invention, the hue is represented by 5Y, the lightness is 8, and the saturation is 10 or more. It is possible to obtain a color corresponding to a vote.

  The model product of the film coating product according to the present invention exhibits excellent disintegration properties that dissolve rapidly in water. In the present invention, as an index for evaluating the disintegration property of the film coating product, a disintegration test using a disintegration tester (device name: NT-2H, manufactured by Toyama Sangyo Co., Ltd.) is performed, and the time required for the disintegration of the film coating product Therefore, a method for evaluating the disintegration degree of each coated product is adopted. The disintegration degree was measured according to the method described in “58. Disintegration test method” described on pages B-619 to B-628 of the 14th revised Japanese Pharmacopoeia Manual (2001, published by Yodogawa Shoten). Is done. Specifically, a basket dedicated to the disintegration degree tester is attached to a receiving shaft, and the basket is smoothly placed in a beaker installed in the disintegration degree tester with 29 to 32 reciprocations per minute and an amplitude of 53 to 57 mm. Is adjusted to move up and down. When the basket is at the lowest position, the mesh surface of the bottom of the basket is 25 mm from the bottom of the beaker, and the amount of test liquid to be placed in the beaker is such that the top surface of the basket matches the surface of the liquid when the basket is at the lowest position. The temperature of the test solution is kept at 37 ± 2 ° C. Pure water is used as a test solution, and one film coating product to be measured is put in each of six glass tubes in a basket. The basket is immersed in a test solution in a beaker whose temperature and amount have been adjusted in advance, and continues to move up and down for a certain period of time, and the time required until no residue is found in the glass tube is measured as the disintegration time. In the present invention, six samples are tested per product, the disintegration time is obtained from the average value, and the disintegration property of the film coating product is evaluated.

  As a result of the above disintegration test, the disintegration time of the film coating product according to the present invention is 30 minutes or less, preferably 25 minutes or less, more preferably 23 minutes or less, and the film coating product has excellent disintegration. I can confirm.

  Hereinafter, the details of the film coating layer, the film coating product, and the manufacturing method thereof according to the present invention will be described in detail with reference to examples, but the technical scope of the present invention is not limited to the following examples. .

  As a hydroxyalkylated dextrin derived from waxy corn starch used in Examples and Comparative Examples, a commercially available product (trade name: PENON PKW, Nissho Kagaku Co., Ltd.) was used. This is obtained by reacting propylene oxide with waxy corn starch to make hydroxypropyl, which is a hydroxypropylated starch having a substitution degree of 0.06, phosphoric acid-crosslinked, and hydrolyzed by enzymatic decomposition. Hydroxypropylated phosphate cross-linked dextrin derived from zero waxy corn. This hydroxypropylated phosphoric acid cross-linked dextrin had a viscosity of 150 cp when made into an aqueous solution with a solid content of 30% by weight and a temperature of 30 ° C.

  The sugar alcohol compositions used in the examples and comparative examples are all commercial products sold by Towa Kasei Kogyo Co., Ltd., “Amarty MR” (trade name, (Registered trademark) and “AMAMIR” (trade name, registered trademark), “PO-60”, “PO-30”, “PO-20” (all trade names) sold in the form of reduced starch saccharified product It was used. The reduced starch saccharified product is a liquid product and has a solid content of 70% by weight. The sugar composition of these sugar alcohols and the viscosity values at a solid temperature of 70% by weight and a liquid temperature of 25 ° C. are shown in Table 1. DP in the table represents Degree of Polymerization, DP = 1 is mainly sorbitol, DP = 2 is maltitol, DP = 3 is mainly maltotriitol, DP ≧ 4 is mainly maltotetrie. This refers to hydride of saccharides having a polymerization degree of 5 or higher with tall.

  The emulsifier used in Examples and Comparative Examples has a glycerin fatty acid ester (trade name: MSW-7S, moisture content: 60%, manufactured by Sakamoto Pharmaceutical Co., Ltd.) having an HLB value of 13.4, and an HLB value of 11.6. Glycerin fatty acid ester (trade name: MS-5S, manufactured by Sakamoto Yakuhin Kogyo Co., Ltd.), sucrose fatty acid ester having an HLB value of 11.0 (trade name: S-1170, manufactured by Mitsubishi Chemical Foods Co., Ltd.), and HLB value of 5 0.0 sucrose fatty acid ester (trade name: S-570, manufactured by Mitsubishi Chemical Foods Corporation) was used. MSW-7S is a paste-like substance having a water content of 60%, and all other emulsifiers are powder products.

  In the examples and comparative examples, a colorant is used for the purpose of coloring the film coating layer. As the colorant, a commercially available product (trade name: Yellow No. 5, manufactured by San-Ei Gen FFI Co., Ltd.) is used as a coating solution containing a colorant-containing aqueous solution having a solid content concentration of 1.0% by weight. It was used by the method of adding to. Hereinafter, this solution is referred to as a 1% colorant solution.

  The core material used in the preparation of the film coating product is a commercially available lactose simulated tablet (tablet diameter: 10 mm, R: 8.5 mm, H: 1.63 mm, average weight: 360 mg / tablet, manufactured by Sankei Health Co., Ltd.) ) Was used.

(Invention 1)
As a raw material of the coating solution, a commercially available product (trade name: PENON PKW) is used as a hydroxyalkylated dextrin derived from waxy corn starch, and a commercially available maltitol-containing honey crystal (trade name: Amalty MR) is used as a sugar alcohol composition. Then, glycerin fatty acid ester (trade name: MSW-7S, water content 60%) having an HLB value of 13.4 was used as an emulsifier. In the preparation of the coating solution, 13.0 parts by weight of the above-mentioned PENON, 2.5 parts by weight of maltitol-containing crystals, 1.0 part by weight of glycerin fatty acid ester, and 84.5 parts by weight of water were blended. . Next, for the purpose of coloring the film coating, 0.5 part by weight of a 1% colorant solution was added to prepare a coating solution having a solid content concentration of 15.7% by weight.
Put 500g of lactose simulated tablets as the core material for film coating products into a fully automatic sugar coating machine (device name: High Coater Lab / HC-LABO, manufactured by Freund Corporation), supply air temperature: 75 ° C, supply air volume : 0.8 cubic meter / min, supply pressure: 0.15 MPa, pan rotation speed 20 rpm, coating solution temperature 25 ° C., coating solution supply rate 4.0 g / min. The coating operation was carried out until a film coating product with an average weight of 371 mg / tablet with a coverage of 3% was obtained. After the coating operation is completed, the air supply temperature in the fully automatic sugar coating machine is 75 ° C., the supply air volume is 0.8 cubic meters / minute, and the supply air pressure is 0.15 MPa for 3 minutes, and then the supply air temperature. A cooling treatment was performed for 10 minutes under the same conditions except that was changed to 30 ° C. Next, the cooled film coating product is sealed in an aluminum storage bag with a zipper (trade name: Rami Zip AL16, produced by Nihon Shasha Co., Ltd.) and allowed to stand at room temperature for 24 hours. (Invention product 1) was prepared.
In preparation of Product 1 of the present invention, the coating time required for the coating layer coverage to reach 3% was 30 minutes.

(Invention 2)
In preparing the coating solution, the same raw materials as in Invention 1 were used, and the blending ratio was 18.5 parts by weight of PENON, 3.5 parts by weight of maltitol-containing crystals, 1.0 part by weight of glycerin fatty acid ester, and 78. A coating solution having a solid content concentration of 22.1% by weight was prepared by changing the proportion to 0.5 parts by weight of 0 part by weight and 1% colorant solution.
Hereinafter, a film coating product (Invention Product 2) was prepared by the same method as Invention Product 1 except that the above-described coating solution was used. In preparation of Product 2 of the present invention, the coating time required for the coating layer coverage to reach 3% was 26 minutes.

(Invention 3)
In preparing the coating solution, the same raw materials as in Invention 1 were used, and the blending ratio was 8.4 parts by weight of PENON, 1.6 parts by weight of maltitol-containing crystals, 1.0 part by weight of glycerin fatty acid ester, 90. The coating solution having a solid content concentration of 10.3 wt% was prepared by changing to 0 wt parts and 0.5 wt parts of 1% colorant solution.
Hereinafter, a film coating product (Invention Product 3) was prepared by the same method as Invention Product 1 except that the above-described coating solution was used. In preparing the product 3 of the present invention, the coating time required for the coating layer coverage to be 3% was 36 minutes.

(Invention 4)
In the preparation of the coating solution, the same raw materials as in Invention 1 were used, and the blending ratio was 13.0 parts by weight of PENON, 3.5 parts by weight of maltitol-containing crystals, 1.0 part by weight of glycerin fatty acid ester, water 83. A coating solution having a solid content concentration of 16.7% by weight was prepared by changing the proportion to 5 parts by weight and 0.5% by weight of the 1% colorant solution.
Hereinafter, a film coating product (Invention Product 4) was prepared by the same method as Invention Product 1 except that the above-described coating solution was used. In preparation of Product 4 of the present invention, the coating time required for the coating layer coverage to be 3% was 29 minutes.

(Invention 5)
In preparing the coating solution, the same raw materials as in Invention 1 were used, and the blending ratio thereof was 13.0 parts by weight of PENON, 1.5 parts by weight of maltitol-containing crystals, 1.0 part by weight of glycerin fatty acid ester, 85. A coating solution having a solid content concentration of 14.7% by weight was prepared by changing the proportion to 5 parts by weight and 0.5% by weight of the 1% colorant solution.
Hereinafter, a film coating product (Invention Product 5) was prepared by the same method as Invention Product 1 except that the above-described coating solution was used. In preparation of Product 5 of the present invention, the coating time required for the coating layer coverage to be 3% was 31 minutes.

(Invention 6)
In preparing the coating solution, the same raw materials as in Invention 1 were used, and the blending ratio thereof was 13.0 parts by weight of PENON, 2.5 parts by weight of maltitol-containing crystals, 0.5 parts by weight of glycerin fatty acid ester, water 84. A coating solution having a solid content concentration of 15.5% by weight was prepared by changing the proportion to 5 parts by weight and 0.5% by weight of the 1% colorant solution.
Hereinafter, a film coating product (Invention Product 6) was prepared by the same method as Invention Product 1 except that the above coating solution was used. In preparation of Product 6 of the present invention, the coating time required for the coating layer coverage to reach 3% was 30 minutes.

(Invention 7)
In preparing the coating solution, the same raw materials as in Invention 1 were used, and the blending ratio was 13.0 parts by weight of PENON, 2.5 parts by weight of maltitol-containing crystals, 2.0 parts by weight of glycerin fatty acid ester, water 84. A coating solution having a solid content concentration of 15.9% by weight was prepared by changing the proportion to 5 parts by weight and 0.5% by weight of the 1% colorant solution.
Hereinafter, a film coating product (Invention Product 7) was prepared by the same method as Invention Product 1 except that the above coating solution was used. In preparation of Product 7 of the present invention, the coating time required for the coating layer coverage to be 3% was 33 minutes.

(Invention 8)
In the preparation of the coating solution, in addition to the same raw materials as Invention 1, hydroxypropylated starch derived from waxy corn (trade name: Clear Text VB-3, manufactured by Nippon Food Chemical Co., Ltd.) is used as an auxiliary for film coating. , PENON 12.5 parts by weight, hydroxypropylated starch 0.5 parts by weight, maltitol honey crystals 2.5 parts by weight, glycerin fatty acid ester 1.0 parts by weight, water 84.5 parts by weight, 1% The colorant solution was mixed at a ratio of 0.5 part by weight to prepare a coating solution having a solid content concentration of 15.7% by weight.
Hereinafter, a film coating product (Invention Product 8) was prepared by the same method as Invention Product 1 except that the above-described coating solution was used. In preparation of Product 8 of the present invention, the coating time required for the coating layer coverage to be 3% was 30 minutes.

(Invention 9)
In preparing the coating solution, glycerin fatty acid ester (trade name: MS-5S) having an HLB value of 11.6 is used as an emulsifier instead of glycerin fatty acid ester (trade name: MSW-7S) having an HLB value of 13.4. Other than that, using the same raw material as invented product 1, the blending ratio was 13.0 parts by weight of PENON, 2.5 parts by weight of maltitol honey crystals, 0.4 parts by weight of glycerin fatty acid ester, 84.5 parts by weight of water. 1 part of the 1% colorant solution was mixed at a ratio of 0.5 parts by weight to prepare a coating solution having a solid concentration of 15.8% by weight.
Hereinafter, a film coating product (Invention Product 9) was prepared by the same method as Invention Product 1 except that the above-described coating solution was used. In preparation of Product 9 of the present invention, the coating time required for the coating layer coverage to be 3% was 35 minutes.

(Invention 10)
In the preparation of the coating solution, the same raw materials as in Invention Product 1 were used except that reduced sugar saccharified product (trade name: PO-60) was used in place of maltitol-containing crystals as the sugar alcohol composition. The ratio was changed to a ratio of 13.0 parts by weight of PENON, 3.57 parts by weight of reduced starch saccharified product, 1.0 part by weight of glycerin fatty acid ester, 83.43 parts by weight of water and 0.5 part by weight of 1% colorant solution. A coating solution having a solid content concentration of 15.7% by weight was prepared.
Hereinafter, a film coating product (Invention Product 10) was prepared by the same method as Invention Product 1 except that the above coating solution was used. In preparing the product 10 of the present invention, the coating time required for the coating layer coverage to reach 3% was 30 minutes.

(Invention 11)
In the preparation of the coating solution, the same raw material as that of Invention 1 was used, except that reduced starch saccharified product (trade name: Amamir) was used as a sugar alcohol composition instead of maltitol-containing crystals. PENON 13.0 parts by weight, reduced starch saccharified 3.57 parts by weight, glycerin fatty acid ester 1.0 part by weight, water 83.43 parts by weight, 1% colorant solution 0.5 parts by weight blended. A coating solution having a solid content concentration of 15.7% by weight was prepared.
Hereinafter, a film coating product (Invention Product 11) was prepared by the same method as Invention Product 1 except that the above-described coating solution was used. In preparation of the product 11 of the present invention, the coating time required for the coating layer coverage to be 3% was 30 minutes.

(Invention 12)
In the preparation of the coating solution, the same raw materials as in Invention Product 1 were used except that reduced sugar saccharified product (trade name: PO-30) was used in place of maltitol-containing crystals as the sugar alcohol composition. The ratio was changed to a ratio of 13.0 parts by weight of PENON, 3.57 parts by weight of reduced starch saccharified product, 1.0 part by weight of glycerin fatty acid ester, 83.43 parts by weight of water and 0.5 part by weight of 1% colorant solution. A coating solution having a solid content concentration of 15.7% by weight was prepared.
Hereinafter, a film coating product (Invention Product 12) was prepared by the same method as Invention Product 1 except that the above-described coating solution was used. In preparation of Product 12 of the present invention, the coating time required for the coating layer coverage to be 3% was 38 minutes.

(Control 1)
In preparing the coating solution, the sugar alcohol composition was the same as Invention Product 1 except that a reduced starch saccharified product (trade name: PO-20) having a low maltitol content was used instead of maltitol-containing crystals. Using raw materials, the blending ratio was PENON 13.0 parts by weight, reduced starch saccharified product 3.57 parts by weight, glycerin fatty acid ester 1.0 part by weight, water 83.43 parts by weight, 1% colorant solution 0.5 part by weight A coating solution having a solid content concentration of 15.7% by weight was prepared.
Hereinafter, except that the above-described coating solution was used, an attempt was made to prepare a film coating product (control product 1) by the same method as invented product 1, but the film coating layer formed in the manufacturing process was used as another core material. The film coating product having a uniform film coating layer could not be obtained.

(Control product 2)
In preparing the coating solution, sucrose fatty acid ester (trade name: S-1170, Mitsubishi) having an HLB value of 11.0 was used instead of glycerin fatty acid ester (trade name: MSW-7S) having an HLB value of 13.4 as an emulsifier. Other than using Chemical Foods Co., Ltd., the same raw materials as in Invention 1 were used, and the blending ratio was 13.0 parts by weight of PENON, 2.5 parts by weight of maltitol-containing honey crystals, 0. A coating solution having a solid content concentration of 15.8% by weight was prepared by changing to 4 parts by weight, 84.5 parts by weight of water, and 0.5 parts by weight of 1% colorant solution.
Hereinafter, a film coating product (control product 2) was prepared by the same method as invention product 1 except that the above-described coating solution was used. In the preparation of Control 2, the coating time required for the coating layer coverage to reach 3% was 54 minutes.

(Control 3)
In preparation of the coating solution, sucrose fatty acid ester (trade name: S-570, Mitsubishi) having an HLB value of 5.0 instead of glycerin fatty acid ester (trade name: MSW-7S) having an HLB value of 13.4 as an emulsifier. Other than using Chemical Foods Co., Ltd., the same raw materials as in Invention 1 were used, and the blending ratio was 13.0 parts by weight of PENON, 2.5 parts by weight of maltitol-containing honey crystals, 0. A coating solution having a solid content concentration of 15.8% by weight was prepared by changing to 4 parts by weight, 84.5 parts by weight of water, and 0.5 parts by weight of 1% colorant solution.
Hereinafter, a film coating product (control product 3) was prepared by the same method as invention product 1 except that the above-described coating solution was used. In the preparation of Control 3, the coating time required for the coating layer coverage to reach 3% was 44 minutes.

(Control 4)
In preparing the coating solution, in place of the hydroxyalkylated dextrin derived from waxy corn starch, maltodextrin having a DE of 5 to 7 (trade name: Fujistar # 5, manufactured by Nippon Shokuhin Kako Co., Ltd.) was used. 1 using the same raw materials as No. 1, maltodextrin 13.0 parts by weight, maltitol honey crystals 2.5 parts by weight, glycerin fatty acid ester 1.0 part by weight, water 84.5 parts by weight, 1% The colorant solution was mixed at a ratio of 0.5 part by weight to prepare a coating solution having a solid content concentration of 15.7% by weight.
Hereinafter, except for using the above-described coating solution, an attempt was made to prepare a film coating product (control product 4) by the same method as invented product 1. However, solidification of the coating solution did not progress during the manufacturing process, and many core materials were used. The film coating product could not be obtained because it was bound and no film coating layer was formed.

(Control 5)
As raw materials for the coating solution, hydroxypropyl methylcellulose (trade name: TC-5, manufactured by Shin-Etsu Chemical Co., Ltd.), glycerin fatty acid ester (trade name: MSW-7S), glycerin (special reagent grade, manufactured by Wako Pure Chemical Industries, Ltd.), A 1% colorant solution was used. In each case, 10.0 parts by weight of hydroxypropylmethylcellulose, 1.0 part by weight of glycerin fatty acid ester, 1.0 part by weight of glycerin, 89.0 parts by weight of water, 0.5 part by weight of 1% colorant solution, A coating solution was prepared.
Hereinafter, a film coating product (control product 5) was prepared by the same method as invention product 1 except that the above-described coating solution was used. In preparation of the control product 5, the coating time required for the coating layer coverage to be 3% was 45 minutes.

(Control product 6)
As a raw material for the coating solution, a beer yeast cell wall-containing solution (trade name: Yeast Wrap, manufactured by Kirin Brewery Co., Ltd.), glycerin (special grade reagent, manufactured by Wako Pure Chemical Industries, Ltd.), and a 1% colorant solution were used. In each case, 99.0 parts by weight of a beer yeast cell wall-containing solution, 1.0 part by weight of glycerin and 0.5 part by weight of a 1% colorant solution were blended to prepare a coating solution.
Hereinafter, a film coating product (control product 6) was prepared by the same method as Invention Product 1 except that the above-described coating solution was used. In preparation of the control product 6, the coating time required for the coating layer coverage to be 3% was 36 minutes.

(Control product 7)
Corn protein powder (trade name: Twein DP, manufactured by Showa Sangyo Co., Ltd.), glycerin (reagent special grade, manufactured by Wako Pure Chemical Industries, Ltd.), 95 vol% ethanol aqueous solution (ethanol is a reagent special grade, Wako Pure Chemical) 1% colorant solution was used. In each case, 8.0 parts by weight of corn protein powder, 1.0 part by weight of glycerin, 77.0 parts by weight of 95 vol% ethanol aqueous solution, 14.0 parts by weight of water, 0.5 parts by weight of 1% colorant solution are blended. A coating solution was prepared.
Hereinafter, a film coating product (control product 7) was prepared by the same method as Invention Product 1 except that the above-described coating solution was used. In preparation of the control product 7, the coating time required for the coating layer coverage to reach 3% was 40 minutes.

(Control 8)
As a raw material for the coating solution, shellac (trade name: Lac Grace 20E, manufactured by Nippon Shellac Co., Ltd.), 1% colorant solution was used. A coating solution was prepared by blending 100.0 parts by weight of shellac and 0.5 parts by weight of a 1% colorant solution, respectively.
Hereinafter, a film coating product (control product 8) was prepared by the same method as invention product 1 except that the above-described coating solution was used. In preparation of this control product 8, the coating time required for the coating layer coverage to reach 3% was 60 minutes or more.

  For the inventive products 1 to 12 and the control products 1 to 8 prepared by the method described in the above preparation example, evaluation test 1: cracks on the surface of the film coating layer, evaluation test 2: glossiness of the film coating layer surface, evaluation test 3: Colorability of film coating layer, evaluation test 4: Disintegration degree of film coating product, the above four items were evaluated. The evaluation test implementation method and evaluation criteria are as follows.

(Evaluation Test 1) Cracks on the surface of the film coating layer For the inventive product and the control product obtained in each of the preparation examples, 20 samples of each product were arbitrarily taken out and 1 at room temperature in a desiccator with a relative humidity of 9%. About what was stored for months, the presence or absence of the crack in the film coating layer surface was confirmed visually, and the number of the film coating products which the crack cracked was counted.

(Evaluation Test 2) Gloss on the surface of the film coating layer About the invention product and the control product obtained in each preparation example, 5 samples of each product were arbitrarily taken out, and gloss meter (device name: GLOSS METER VG-2000, Japan) The glossiness of the film coating product was measured by Denshoku Industries Co., Ltd.). In the gloss measurement using the gloss meter, a dedicated sample stage (apparatus name: φ6 attachment) with a 6 mm circular hole formed in the center of the apparatus is used as the sample stage, and a 75-degree specular gloss method is used. Five samples were measured under the measurement conditions of an incident angle of 75 ° and a light receiving angle of 75 °, and the average value was defined as the glossiness of the product.

(Evaluation Test 3) Gloss and Colorability of Film Coating Layer Regarding the invention product and control product obtained in each preparation example, 5 samples of each product were taken out arbitrarily, and the gloss of the film coating layer surface and 1% colorant The yellow color developed by the solution was evaluated visually by a trained panelist. The yellow color is obtained with each color chart described in the JIS-Z-8721 standard color chart gloss version (issue: Japanese Standards Association, production: Japan Color Research Institute) and each preparation example. The products were evaluated in a manner that the trained panelists contrasted to determine the HV / C for each product. H represents Hue (hue), V represents Value (lightness), and C represents Chroma (saturation).

(Evaluation test 4) Disintegration degree of film-coated product For each of the invention products and control products obtained in each preparation example, 6 samples of each product were arbitrarily taken out, and a disintegration tester (device name: NT-2H, Toyama Sangyo) The degree of disintegration was measured using a The disintegration degree was measured according to the method described in “58. Disintegration test method” described on pages B-619 to B-628 of the 14th revised Japanese Pharmacopoeia Manual (2001, published by Yodogawa Shoten). Is done. Specifically, a basket dedicated to the disintegration degree tester is attached to a receiving shaft, and the basket is smoothly placed in a beaker installed in the disintegration degree tester with 29 to 32 reciprocations per minute and an amplitude of 53 to 57 mm. Is adjusted to move up and down. When the basket is at the lowest position, the mesh surface of the bottom of the basket is 25 mm from the bottom of the beaker, and the amount of test liquid to be placed in the beaker is such that the top surface of the basket matches the surface of the liquid when the basket is at the lowest position. The temperature of the test solution is kept at 37 ± 2 ° C. Pure water is used as a test solution, and one film coating product to be measured is put in each of six glass tubes in a basket. The basket is immersed in a test solution in a beaker whose temperature and amount have been adjusted in advance, and continues to move up and down for a certain period of time, and the time required until no residue is found in the glass tube is measured as the disintegration time. In the present invention, six samples were tested per product, the disintegration time was obtained from the average value, and the disintegration property of the film coating product was evaluated.

  Table 9 shows the results of the evaluation tests 1 to 4 carried out for each of the invention products and control products obtained in each of the preparation examples.

Claims (9)

A hydroxyalkylated dextrin derived from waxy corn starch, a sugar alcohol composition having a maltitol content of 15.0 wt% or more and 99.0 wt% or less in terms of solids, and a glycerin fatty acid having an HLB value of 11 to 14 A film coating layer mainly composed of three components of ester. The content in terms of solid content is 70.0 to 95.0% by weight of hydroxyalkylated dextrin, 3.0 to 28.0% by weight of sugar alcohol composition, and 0.1 to 10.0 of glycerin fatty acid ester. The film coating layer according to claim 1, wherein the film coating layer is in wt%. The film coating layer according to claim 1 or 2, wherein the hydroxyalkylated dextrin is a hydroxypropylated dextrin. The film coating layer according to any one of claims 1 to 3, wherein the dextrose equivalent (DE) of the hydroxyalkylated dextrin is 0.1 or more and less than 5.0. The film coating layer according to any one of claims 1 to 4, wherein the hydroxyalkylated dextrin is crosslinked with a crosslinking agent. The film coating layer according to any one of claims 1 to 5, wherein when the hydroxyalkylated dextrin is an aqueous solution having a solid content of 30% by weight and a temperature of 30 ° C, the viscosity of the aqueous solution is 50 to 350 cp. The film coating layer according to any one of claims 1 to 6, wherein when the sugar alcohol composition is an aqueous solution having a solid content of 70% by weight and a temperature of 25 ° C, the viscosity of the aqueous solution is 150 to 1500 cp. A film-coated product, wherein the core material is coated with the film-coating layer according to any one of claims 1 to 7. The content in terms of solids is 70.0-95.0% by weight of hydroxyalkylated dextrin derived from waxy corn starch, and the maltitol content is 15.0% by weight to 99.0% by weight in terms of solids A coating solution comprising a sugar alcohol composition in the range of 3.0 to 28.0% by weight and a glycerin fatty acid ester in the range of 0.1 to 10.0% by weight is prepared, and the prepared coating solution is film-coated. A film coating comprising: applying to a core material to be coated with a layer; and drying the coating solution applied around the core material until a desired film coating layer is formed Product manufacturing method.