JP2015091767A - Coated tablet - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a coated tablet which can prevent browning of enzymolytic royal jelly and can mask a bad smell, and can also streamline coating.SOLUTION: The invention provides a coated tablet having an uncoated tablet and a coating layer which coats the uncoated tablet. The coating layer contains a coating component, reduction malt sugar, and a thickener.

Description

  The present invention relates to coated tablets.

  Royal jelly is a useful natural material, but it is known that it can cause allergic reactions. Therefore, various methods for reducing the amount of allergen by degrading and reducing the molecular weight of a protein that can be an allergen have been studied.

  For example, as a method for reducing the amount of allergen for royal jelly, in other words, a method for preparing a low allergenized royal jelly, a method of subjecting royal jelly to glycolytic enzyme treatment and proteolytic enzyme treatment (Patent Document 1), royal jelly to end-type neutrality A method of performing peptidase treatment (Patent Document 2), a method of performing one-step enzyme treatment with an alkaline peptidase having both an endopeptidase action and an exopeptidase action (Patent Document 3), and an enzyme having an endopeptidase action and an exopeptidase action There has been proposed a method (Patent Document 4) or the like in which an enzyme treatment is carried out simultaneously or sequentially using an enzyme having the following.

  In particular, the method described in Patent Document 3 prevents the loss or significant reduction of physiological activity that occurs when endopeptidase and exopeptidase are used in combination, while maintaining the useful physiological activity of royal jelly, This is a useful method in that it can be reduced.

  However, royal jelly (enzyme-degraded royal jelly) that has been decomposed by peptidase and reduced to allergen is more susceptible to temperature and humidity than a non-enzymatic treated royal jelly, and is liable to be browned and colored. Such coloring is considered to be due to the Maillard reaction that occurs between the amide group of the peptide or amino acid fragmented by the enzyme treatment and the anomeric carbon of the reducing sugar.

  Furthermore, the enzymatically decomposed royal jelly also has a problem of strong odor. Therefore, when selling enzymatically degraded royal jelly as a health food, it is necessary to prevent browning and mask the odor. Examples of commercially available health foods of enzyme-degraded royal jelly include those in the form of tablets in which a base tablet of enzyme-decomposed royal jelly is coated with sugar coating.

  Patent Document 5 discloses an uncoated tablet composed of a dry powder royal jelly, an excipient and a lubricant, an enteric coating formed on the surface of the uncoated tablet, a sugar coating layer covering the coating, and a sugar coating layer on the coating layer. It describes a royal jelly tablet characterized in that a glossy layer is formed, and the royal jelly tablet is not dissolved by gastric juice, has excellent enteric properties, and can maintain stable quality over a long period of time. ing.

JP 2002-112715 A JP 2005-287411 A JP 2007-295919 JP 2007-295920 A Japanese Patent Laid-Open No. 10-191904

  However, when an enzyme-degraded royal jelly uncoated tablet is coated with a sugar coating to mask odor, there is a problem that the coating of the sugar coating tends to be thick.

  Further, Patent Document 5 discloses a royal jelly tablet, but there is no description about an enzyme-degraded royal jelly, and no coating for the purpose of preventing browning of the enzyme-degraded royal jelly and masking odor is disclosed. .

  Accordingly, an object of the present invention is to provide a coated tablet that can prevent browning of an enzymatically-degraded royal jelly and mask odor, and can be slimmed down.

  The inventors of the present invention include an uncoated tablet containing an enzymatically degraded royal jelly, a layer containing hydroxypropylmethylcellulose (hereinafter sometimes abbreviated as HPMC), a layer containing HPMC and gelatin or gum arabic, and reduced maltose. It was found that the above-mentioned purpose can be achieved by coating with three layers.

  Based on these findings, the present invention has been completed through further studies, and provides the following coated tablets.

(I) Coated tablets
(I-1) A coated tablet comprising an uncoated tablet and a coating layer covering the uncoated tablet, wherein the coated layer contains a coating component, reduced maltose and a thickener.
(I-2) The coated tablet according to (I-1), wherein the coating component is a cellulose-based film-forming component.
(I-3) The coated tablet according to (I-2), wherein the cellulose-based film-forming component is hydroxypropylmethylcellulose.
(I-4) The coated tablet according to any one of (I-1) to (I-3), wherein the thickener is gelatin and / or gum arabic.
(I-5) The coated tablet according to any one of (I-1) to (I-4), wherein the coating layer has a three-layer structure.
(I-6) The coated tablet according to (I-5), wherein the three layers are composed of the layers shown in the following (A) to (C):
(A) a layer containing a coating component,
(B) a layer containing a coating component and a thickener, and
(C) Layer containing reduced maltose.
(I-7) The coated tablet according to any one of (I-1) to (I-6), wherein the uncoated tablet contains a highly hygroscopic substance.
(I-8) The coated tablet according to any one of (I-1) to (I-6), wherein the uncoated tablet contains an enzymatically decomposed royal jelly, a royal jelly extract or a raw royal jelly dry powder.
(I-9) The coated tablet according to any one of (I-1) to (I-8), which is used as a food.

  The coated tablet of the present invention can prevent browning of substances contained in the uncoated tablet (particularly enzyme-degraded royal jelly) and mask odor, and can also make the coating layer slimmer than a coating with only a sugar coating.

It is a graph which shows the result of Experiment 1 (browning evaluation). It is a graph which shows the result of Test Example 2 (odor evaluation).

  Hereinafter, the present invention will be described in detail.

  The coated tablet of the present invention is a coated tablet having an uncoated tablet and a coated layer covering the uncoated tablet, wherein the coated layer contains a coating component, reduced maltose and a thickener.

  In the present invention, the uncoated tablet contains an excipient, a disintegrant, a binder, a lubricant, a colorant, etc., in addition to a component that needs to prevent browning and mask odor (hereinafter referred to as component α). It may be. These excipients, disintegrants, binders, lubricants, and coloring agents are not particularly limited, and known ones used for tablet production can be used. The uncoated tablet is produced, for example, by granulating and sizing component α together with an excipient, a disintegrant, a binder, and the like, and then mixing the lubricant with the obtained sized powder and tableting. Can do. The content of component α in the uncoated tablet is preferably 10 to 100% by weight, more preferably 70 to 100% by weight.

  Component α contained in the uncoated tablet may be either a medicine or a food. The component α is preferably a substance that easily changes color due to the influence of temperature and humidity and has a strong odor. Examples of the component α include a highly hygroscopic substance. Here, the highly hygroscopic substance means a substance whose weight increase rate is 2% or more in 20 minutes under the conditions of 75% humidity and 40 ° C. As the component α, an enzymatically decomposed royal jelly, a royal jelly extract or a raw royal jelly dry powder is preferable, and an enzymatically decomposed royal jelly is particularly preferable.

  Royal jelly is a milky white jelly-like substance made by mixing the secreted secretions of 3 to 12 days old bees from the hypopharyngeal gland and the greater vagina. The main physiologically active ingredients in royal jelly include, for example, organic acids such as 10-hydroxydecenoic acid (hereinafter referred to as “decenoic acid”), which are unique to royal jelly, proteins, lipids, saccharides, vitamin Bs, Vitamins such as folic acid, nicotinic acid, pantothenic acid, various minerals, and the like. As the physiological activity and pharmacological action of this royal jelly, antibacterial action, immune enhancing action, antidepressant action, antitumor action, anti-inflammatory action, blood flow increasing action and the like are known. In addition, the side effects of anticancer drugs are reduced and the life-prolonging effect at the time of radiation injury is also reported.

  The royal jelly used in the production of the enzyme-degraded royal jelly is not limited, but raw royal jelly, royal jelly powder obtained by drying raw royal jelly and powdered, or raw royal jelly extracted with water or water-containing ethanol can be used. .

  In the present invention, the term “royal jelly” includes, in addition to raw royal jelly, a processed product obtained by subjecting the raw royal jelly to drying or pulverization treatment, unless otherwise specified.

  The production area of royal jelly is not limited and may be any of Japan, China, Brazil, European countries, Oceania countries, the United States, and the like.

  The enzymatically degraded royal jelly targeted by the present invention is obtained by treating royal jelly with a proteolytic enzyme (peptidase). Preferably, it is a low allergenase degrading royal jelly in which an allergic reaction caused by a protein contained in the royal jelly is suppressed by peptidase treatment. Therefore, the enzyme-degraded royal jelly of the present invention may include organic acids such as decenoic acid, lipids, saccharides, vitamins, and various minerals in addition to the above-described peptidase degradation products of proteins contained in the royal jelly.

  Peptidase can be preferably exemplified as the enzyme used for enzymatic degradation of royal jelly. The peptidase used may have at least one of an endopeptidase action and an exopeptidase action, but preferably has at least an endopeptidase action, and more preferably has both of these actions.

  The enzyme-degraded royal jelly of the present invention is preferably one that has been made low in allergen by hydrolyzing a protein contained in the royal jelly. For this purpose, it is preferable to hydrolyze the royal jelly using at least a peptidase having an endopeptidase action (endopeptidase), preferably using a peptidase having both an endopeptidase action and an exopeptidase action. Here, as a peptidase having both an endopeptidase action and an exopeptidase action, a peptidase having both actions at the same time may be used alone, or a peptidase having an endopeptidase action (endopeptidase) and an exopeptidase action. May be used in combination with a peptidase having the following structure (exopeptidase).

  The endopeptidase that can be used in the present invention may be any proteolytic enzyme having at least endopeptidase activity. For example, endopeptidases derived from animals (for example, trypsin, chymotrypsin, etc.), plants (for example, papain, etc.), or microorganisms (for example, lactic acid bacteria, yeast, mold, Bacillus subtilis, actinomycetes, etc.) can be widely exemplified. it can.

  The exopeptidase may be any proteolytic enzyme having at least exopeptidase activity. For example, carboxypeptidase, aminopeptidase, or exopeptidase derived from microorganisms (for example, lactic acid bacteria, Aspergillus sp., Rhizopus sp., Etc.), or pancreatin, pepsin, etc. having endopeptidase activity can also be exemplified.

  By the way, peptidases include exopeptidases having substantially only exopeptidase action, endopeptidases having substantially only endopeptidase action, and peptidases having both exopeptidase action and endopeptidase action. Among these, an enzyme having both an exopeptidase action and an endopeptidase action can be used as an “endopeptidase” when the endopeptidase action is strong, and an “exopeptidase” when the exopeptidase action is strong. When the exopeptidase action and the endopeptidase action are equivalent or almost equivalent, the peptidase can be used as a peptidase having an endopeptidase action and an exopeptidase action at the same time.

  Among such peptidases, preferred examples of enzymes having an exopeptidase action include, for example, Aspergillus oryzae-produced peptidases (trade names: Ummamizyme G, Promod 192P, Promod 194P, Sumiteam FLAP), Aspergillus soe ( Aspergillus sojae) -produced peptidase (trade name: Sternzyme B15024), Aspergillus genus-produced peptidase (trade name: cochlase P), Rhizopus oryzae-produced peptidase (trade name: peptidase R).

  In addition, preferable examples of peptidases having endopeptidase activity include, for example, Bacillus subtilis-producing peptidase (trade name: orientase 22BF, nucleicin), Bacillus licheniformis-producing peptidase (trade name). : Alcalase), Bacillus stearothermophilus production peptidase (trade name: Protease S), Bacillus amyloliquefaciens production peptidase (trade name: Neutase), Bacillus genus production peptidase ( (Trade name: Protamex).

  Furthermore, preferred examples of peptidases having both exopeptidase action and endopeptidase action, particularly alkaline peptidase, include, for example, Streptomyces griseus-produced peptidase (trade name: actinase AS), Aspergillus oryzae (Aspergillus oryzae). ) Produced peptidase (trade name: protease A, flavorzyme), Aspergillus melleus produced peptidase (trade name: protease P). According to the enzyme treatment using such a peptidase, the protein can be made into a low molecular weight by one-step enzyme treatment, so that the operation is simple and the physiological activity of useful components contained in the royal jelly is lost or greatly reduced. There is an advantage that it can be prevented.

  The amount of peptidase used for royal jelly varies depending on the concentration of royal jelly used, enzyme titer, reaction temperature and reaction time, but in general, peptidase is used at a rate of 50 to 10000 action units per gram of protein contained in royal jelly. It is preferable. At this time, peptidase may be added to the royal jelly at once, or may be added in small portions.

  In the peptidase treatment, the pH of the royal jelly is selected from the range of pH 2 to 12, preferably pH 7.5 to 10, more preferably pH 7.8 to 9, corresponding to the optimum pH of the enzyme used. Specifically, before adding the peptidase to the royal jelly, depending on the type of enzyme used, an acid, a pH of 2-12, preferably pH 7.5-10, more preferably pH 7.8-9. The pH is adjusted to a desired value by adding an alkali agent or a buffer. In this case, the acid is hydrochloric acid, sulfuric acid, nitric acid, phosphoric acid, acetic acid, etc .; the alkaline agent is sodium hydroxide, potassium hydroxide, potassium carbonate, etc .; and the buffering agent is phosphate buffer, citric acid, etc. An acid buffer etc. can be illustrated, respectively.

  The temperature of the peptidase treatment is not particularly limited, and a peptidase action, preferably an endopeptidase action, more preferably a range that can be put to practical use, including an optimum temperature range in which both an endopeptidase action and an exopeptidase action appear. That is, it is usually selected from the range of 30 to 70 ° C. By maintaining the temperature at a temperature lower or higher than the optimum temperature of the peptidase (preferably about 40-50 ° C.), for example, in the range of 50-60 ° C., spoilage in the peptidase treatment step can be prevented. The time for the peptidase treatment depends on the reaction conditions such as the type of enzyme used, reaction temperature, and pH, and is not particularly limited.

  Royal jelly can be subjected to proteolytic enzyme treatment as it is or dissolved or dispersed in water. However, when these are in a dry form, they are subjected to proteolytic enzyme treatment in a state dissolved in water. It is preferable.

  The peptidase treatment is stopped by inactivating or removing the peptidase. The deactivation operation can be performed by heat treatment (for example, at 85 ° C. for 15 minutes).

  The enzymatically degraded royal jelly in the present invention may be at least a royal jelly treated with a peptidase as described above, and not only a peptidase treatment but also a combination treatment with other enzymes, for example, a royal jelly treated with a glycolytic enzyme in combination with a peptidase treatment. included.

  The royal jelly extract targeted by the present invention is obtained by extracting royal jelly (including raw, dried and pulverized products) with water or hydrous ethanol.

  Moreover, the raw royal jelly dry powder targeted by the present invention is a powder obtained by drying raw royal jelly.

  Although it will not specifically limit as a coating component in this invention if the effect of this invention is acquired, Preferably it is a cellulose-type film formation component. The cellulose-based film-forming component means a cellulose derivative in which a hydrophobic group (for example, methyl group, hydroxypropyl group, etc.) and / or a hydrophilic group is introduced into a hydroxyl group of cellulose at a predetermined ratio. Examples of the cellulose-based film forming agent include hydroxypropyl methylcellulose (hypromellose) (HPMC2910, HPMC2208, HPMC2906, etc.), hydroxypropylcellulose, low-substituted hydroxypropylmethylcellulose and the like, and hydroxypropylmethylcellulose is particularly preferable. The coating components may be used alone or in combination of two or more.

  Reduced maltose, also called maltite or maltitol, is a disaccharide alcohol having the structure of 4-α-D-glucopyranosyl-D-glucitol. Reduced maltose can be obtained by reducing maltose.

  The thickener in the present invention is not particularly limited as long as the effects of the present invention can be obtained, but gelatin or gum arabic is preferable.

  Gelatin is a product obtained by solubilizing and purifying fibrous protein collagen contained in animal bones, skin, tendons and the like by heating, acid or alkali treatment with water. Gelatin can be obtained from various animal raw materials with various degrees of purification, and thereby may have different physicochemical properties. However, as long as the effects of the present invention are obtained, gelatin of any origin and degree of purification can be used. Can be used.

Gum arabic is also called gum arabic and is a water-soluble, low-viscosity acidic heteropolysaccharide that can be collected mainly from trees of the leguminous acacia genus. In general, the molecular weight is about 2 × 10 ^{5 to} 3 × 10 ⁵ , and it is composed of L-arabinose, D-galactose, D-glucuronsan, L-rhamnose and the like. Since this gum arabic is dissolved in a solvent such as water and then subjected to treatments such as filtration and sterilization, dried processed products such as spray-dried products are commercially available. These can also be used.

  In the present invention, the coating layer covering the uncoated tablet preferably has a three-layer structure. The three layers are preferably composed of three layers: (A) a layer containing a coating component, (B) a layer containing a coating component and a thickener, and (C) a layer containing reduced maltose. The (A) to (C) layers are layers corresponding to any of the underlayer, the intermediate layer, and the upper layer. The uncoated tablet is coated in the order of the underlayer, the intermediate layer, and the upper layer. The coated tablet of the present invention may have a layer other than the above three layers.

  In the layer (A), in addition to the coating components, thickeners (gelatin, gum arabic etc.), adsorbents (light anhydrous silicic acid, hydrous silicon dioxide, magnesium silicate etc.), colorants (titanium oxide etc.), Lubricants (such as glycerin and talc) and binders (such as starch, dextrin, and gum arabic) may be included. The amount of the coating component used is preferably 1 to 20% by weight based on the (A) layer coating solution. Such a layer (A) is formed for the purpose of preventing moisture absorption of the substance contained in the uncoated tablet.

  The layer (A) is prepared by dissolving or suspending the components for the layer (A) in a solvent such as water to prepare a coating solution, and then coating with the coating solution using a known film coating formation method. Can be formed.

  In addition to the coating component and thickener, the layer (B) includes an adsorbent (light anhydrous silicic acid, hydrous silicon dioxide, magnesium silicate, etc.), a colorant (titanium oxide, etc.), and a lubricant that improves fluidity. Agents (such as glycerin and talc), binders (such as starch, dextrin, and gum arabic) may be included. The use amount of the coating component is preferably 1 to 20% by weight with respect to the (B) layer coating solution, and the use amount of the thickener is preferably 1 to 20% by weight with respect to the (B) layer coating solution. It is. Such a layer (B) is formed for the purpose of preventing browning of the substance contained in the uncoated tablet and for the purpose of preventing moisture absorption.

  The layer (B) is prepared by dissolving or suspending the components for the layer (B) in a solvent such as water to prepare a coating solution, and then coating with the coating solution using a known film coating forming method. Can be formed.

  In the layer (C), in addition to the reduced maltose, a bulking agent (talc, precipitated calcium carbonate, calcium hydrogen phosphate, calcium phosphate, calcium sulfate, etc.), a surfactant (polyethylene glycol, etc.), a disintegrant (carmellose calcium, Low-substituted hydroxypropyl methylcellulose, starch, agar powder, etc.), dispersant (light anhydrous silicic acid, etc.), colorant (titanium oxide, etc.), binder (starch, dextrin, gum arabic, etc.), thickener (gum arabic) Etc.) may be included. The amount of reduced maltose used is preferably 1 to 40% by weight based on the (C) layer coating solution. Such a layer (C) is formed for the purpose of preventing moisture absorption of the substance contained in the uncoated tablet and masking odor.

  For layer (C), using a commonly used coating machine, a known sugar coating formation method is used, and a coating solution in which the components for layer (C) are dissolved or suspended in a solvent such as water is added and spread. It can be formed by repeated stretching and drying.

  Further, after forming the top layer, glazing may be performed by a known method. Examples of the brightening agent include carnauba wax, owl, beeswax, shellac, castor oil and the like.

  The coated tablet of this invention can be used as a pharmaceutical or a food, and can be used suitably especially as a food.

  The coated tablet of the present invention can prevent browning of substances contained in the uncoated tablet and mask odor by the coating layer. In addition, suppression of the Maillard reaction (inhibition of browning) means that oxidation is suppressed, and the coated tablet of the present invention is considered to have an effect of suppressing oxidation of the substance contained in the uncoated tablet. . Furthermore, according to the present invention, the above-described effect can be obtained even when the weight of the coating layer is reduced to about one third as compared with the coating with sugar coating only. Therefore, according to the present invention, the coating can be slimmed down, and as a result, the tablet can be made small, so that it is possible to produce a tablet that is easy to drink.

  Examples are given below to illustrate the present invention in more detail. However, the present invention is not limited to these examples.

Example 1
First, the raw materials listed in Table 1 were mixed with a Boule container mixer (Koto Kogyo), and the resulting mixed powder was manufactured with a tableting machine (HT-CVX-MS, Hata Iron Works) to a weight of 330 mg. Locked. For the obtained uncoated tablet, an undercoat solution prepared with the raw materials shown in Table 2, an intermediate coat solution prepared with the raw materials shown in Table 3, an overcoat solution prepared with the raw materials shown in Table 4, Using the raw materials for finishing shown in Table 5, coating with 80 mg was performed with a coating machine (DRC-1400DS, POWREC) to obtain a film-coated tablet having a tablet diameter × tablet thickness: 9.5 × 5.8 mm, weight: 410 mg. .

Example 2
First, the raw materials listed in Table 1 were mixed with a Boule container mixer (Koto Kogyo), and the resulting mixed powder was manufactured with a tableting machine (HT-CVX-MS, Hata Iron Works) to a weight of 330 mg. Locked. For the obtained uncoated tablet, an undercoat solution prepared with the raw materials shown in Table 6, an intermediate coat solution prepared with the raw materials shown in Table 7, an overcoat solution prepared with the raw materials shown in Table 8, Using the finishing raw materials shown in Table 9, coating with 76 mg was performed with a coating machine (DRC-1400DS, Powrec) to obtain film-coated tablets having a tablet diameter × tablet thickness; 9.4 × 5.9 mm, weight: 406 mg.

Example 3
The tablet diameter × tablet was prepared in the same manner as in Example 1 except that gum arabic was used in place of gelatin as the raw material in the undercoat solution and gum arabic was used in place of gelatin as the raw material in the intermediate coat solution. A film-coated tablet having a thickness of 9.5 × 5.8 mm and a weight of 410 mg was obtained.

Comparative Example 1
First, the raw materials listed in Table 10 were mixed with a Boule container mixer (Koto Kogyo), and the resulting mixed powder was manufactured using a tableting machine (HT-CVX-MS, Hata Iron Works) to a weight of 300 mg. Locked. For the obtained uncoated tablet, a zein coat solution prepared with the raw materials shown in Table 11, an undercoat solution prepared with the raw materials shown in Table 12, an overcoat solution prepared with the raw materials shown in Table 13, Table 14 The coating material (DRC-1400DS, POWREC) was used to coat 290 mg, and a sugar-coated tablet having a tablet diameter × tablet thickness: 10.5 × 6.5 mm, weight: 590 mg was obtained.

Comparative Example 2
First, the raw materials listed in Table 1 were mixed with a Boule container mixer (Koto Kogyo), and the resulting mixed powder was manufactured with a tableting machine (HT-CVX-MS, Hata Iron Works) to a weight of 330 mg. Locked. For the obtained uncoated tablet, an undercoat solution prepared with the raw materials shown in Table 15, an intermediate coat solution prepared with the raw materials shown in Table 16, an overcoat solution prepared with the raw materials shown in Table 17, Using the raw materials for finishing shown in Table 18, 58 mg coating was carried out with a coating machine (DRC-1400DS, POWREC) to obtain a film-coated tablet having a tablet diameter x tablet thickness; 9.4 x 5.8 mm, weight: 388 mg. .

Comparative Example 3
First, the raw materials listed in Table 1 were mixed with a Boule container mixer (Koto Kogyo), and the resulting mixed powder was manufactured with a tableting machine (HT-CVX-MS, Hata Iron Works) to a weight of 330 mg. Locked. For the obtained uncoated tablet, an undercoat solution prepared with the raw materials shown in Table 19, an intermediate coat solution prepared with the raw materials shown in Table 20, an overcoat solution prepared with the raw materials shown in Table 21, Using the finishing raw materials shown in Table 22, 67 mg coating was carried out with a coating machine (DRC-1400DS, POWREC) to obtain a film-coated tablet having a tablet diameter × tablet thickness: 9.4 × 5.7 mm, weight: 397 mg .

  It shows in Table 23 about the component contained in the coating layer of the tablet of Examples 1-3 and Comparative Examples 1-3.

Test Example 1: 100 browning evaluation tablets and 1 Care Dry CP1M (manufactured by Oe Chemical Co., Ltd.) were sealed in a brown frost bottle (PS No. 11). The brown frost bottle filled with the tablets was left in an electronic cold / hygrostat (manufactured by ADVANTEC) for 4 weeks in an environment of a temperature of 40 ° C. and a humidity of 75%. Four weeks later, the tablet cross section was measured with a spectroscopic colorimeter (SE-2000 / manufactured by Nippon Denshoku Industries Co., Ltd.). The value was recorded by reading the L value indicating the brightness. The L value is represented by 0-100, indicating black when close to 0, and white when close to 100.

  The results are shown in Table 24 and FIG.

  What is common to Example 1 and Comparative Examples 2-3 is that HPMC is used for the coating agent. By changing from sugar coating to HPMC coating, it was possible to suppress browning of uncoated tablets containing enzymatically degraded royal jelly.

Test Example 2: Odor evaluation tablets 100 tablets and Care Dry CP1M (manufactured by Oe Chemical Co., Ltd.) were enclosed in a brown frost bottle (PS No. 11). The bottle was left to stand in an electronic cold / hygrostat (manufactured by ADVANTEC) for 3 days in an environment of 50 ° C. and 75% humidity. Three days later, volatile odor was measured with a portable odor sensor (manufactured by Shin Cosmos Electric Co., Ltd.). The odor intensity at that time was recorded.

  The results are shown in Table 25 and FIG.

  By simply removing the sugar coating and replacing it with the HPMC coating, it was not possible to suppress odor leakage from the tablets. It was confirmed that the use of the combination of HPMC + thickener + reduced maltose significantly suppressed odor leakage.

Claims (9)

  A coated tablet comprising an uncoated tablet and a coating layer covering the uncoated tablet, wherein the coated layer contains a coating component, reduced maltose and a thickener.   The coated tablet according to claim 1, wherein the coating component is a cellulosic film-forming component.   The coated tablet according to claim 2, wherein the cellulosic film-forming component is hydroxypropylmethylcellulose.   The coated tablet according to any one of claims 1 to 3, wherein the thickener is gelatin and / or gum arabic.   The coated tablet according to any one of claims 1 to 4, wherein the coating layer has a three-layer structure. The coated tablet according to claim 5, wherein the three layers are composed of layers shown in the following (A) to (C):
(A) a layer containing a coating component,
(B) a layer containing a coating component and a thickener, and
(C) Layer containing reduced maltose.   The coated tablet according to any one of claims 1 to 6, wherein the uncoated tablet contains a highly hygroscopic substance.   The coated tablet according to any one of claims 1 to 6, wherein the uncoated tablet contains an enzyme-degraded royal jelly, a royal jelly extract or a raw royal jelly dry powder.   The coated tablet according to any one of claims 1 to 8, which is used as food.

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