JPH10191904A - Royal jelly tablet suppressing quality deterioration and its production - Google Patents

Abstract

PROBLEM TO BE SOLVED: To obtain a royal jelly tablet which is not dissolved by the gastric juice, has an excellent enteric solubility, is capable of maintaining stable quality for a long period of time and suppresses its quality deterioration. SOLUTION: The stock tablets formed by drying a granular mixture formed by mixing and agitating dry powder royal jelly, shaping agent and lubricants to a tabletable state and tableting this granular mixture by a tableting machine is subjected to film forming to impart the enteric property thereto and is then subjected to applying glycocalyx. The layers applied with glycocalyx are subjected to a brightening treatment.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

[0001] The present invention relates to a royal jelly tablet which prevents brown or brown discoloration due to oxidation and suppresses quality deterioration due to decomposition of components contained in gastric juice, and a method for producing the same.

[0002]

2. Description of the Related Art Royal jelly, also called royal milk, is a substance secreted by the worker bee from the pharyngeal gland in the head, and is stored in a nest on a nest box as bait for queen bees. This is completely different from the honey that worker bees collect flower nectar and store in the hive.It contains proteins, vitamins and various minerals, etc., and nutrients necessary for maintaining human health are It is well-balanced.

The components of royal jelly have a water content of 62-70.
%, Crude protein 12-15%, crude fat 3-5%, carbohydrate about 15%, ash about 1.5%, appearance is a white paste-like fluid with an exciting sour taste. Trace components include various amino acids, phosphate conjugates, vitamins, fatty acids,
Contains minerals (March 25, 1992, published by Dobunshoin, 6th edition, 8th edition, edited by Yoshito Sakurai, "Pochette General Food Dictionary", page 1020).

[0004] As described above, royal jelly is used as a health food because it is useful for maintaining health. However, in the air, a part of the contained components is oxidized, so that the color changes from brown to brown. Since the quality is remarkably deteriorated, various proposals have been made to maintain the freshness. That is, it is known that, when royal jelly is preserved by drying to reduce the moisture content, handling is easy and there is little deterioration. Also, it has been proposed to granulate royal jelly using gelatin or the like or to encapsulate the royal jelly in a capsule for convenience in taking (Japanese Patent Publication No. 3-49543, Japanese Patent Application Laid-Open No. 4-36159,
Japanese Patent Publication No. 4-39305, Japanese Patent Publication No. 5-87216).

[0005]

However, simply granulated or encapsulated products inevitably suffer from deterioration in quality due to oxidation in the air, and when taken, some of the components contained in royal jelly due to gastric juice. Has been degraded and its nutritional value has been reduced. An object of the present invention is to provide a royal jelly tablet and a method for producing the royal jelly tablet, which solve the problems in the prior art described above, have no deterioration in quality even after long-term storage, and have no loss of nutritional value even when taken. I have.

[0006]

Means for Solving the Problems In order to achieve the above object, the present inventors have conducted intensive studies and found that the treatment of royal jelly was carried out at a low humidity and a low temperature, and after the raw materials were compressed, the intestine was inoculated. The inventors have found that it is effective to apply a coating of a soluble film, and have completed the present invention.

That is, the present invention based on the above-mentioned findings provides an uncoated tablet comprising dry powder royal jelly, an excipient and a lubricant, an enteric coating formed on the surface of the uncoated tablet, And a royal jelly tablet which suppresses quality deterioration, characterized in that a glossy layer is formed on the sugar coating layer.

[0008] The present invention also provides a dry powder royal jelly,
The granulated mixture formed by mixing and stirring the excipient and the lubricant is dried to a tabletable state, and the granulated mixture is compressed with a tablet machine to give enteric coating to the uncoated tablet. The gist of the present invention is a method for producing a royal jelly tablet in which quality deterioration is suppressed, which is characterized in that a sugar coating is applied after coating, and a glossing treatment is applied to the sugar coating layer.

[0009]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The construction and operation of the present invention will be described.
An object of the present invention is to prevent a decrease in the quality of royal jelly as a health food. The reduction in quality is to prevent the tablet from browning due to oxidation and to prevent the nutritional components from being decomposed by gastric juice when taken. The inventor requested the Osaka City University School of Medicine,
Experimental results of how gastric juice acts on royal jelly have revealed that a part of the protein in royal jelly is degraded and the nutritive value is reduced accordingly.

In order to produce high quality royal jelly products, attention must be paid to the deterioration of components from the stage of raw material collection. The royal jelly, which is the main ingredient of the raw material used in the present invention, is collected 1-2 days earlier than the case where it is usually collected from the beekeeper's mount so that the quality of the components is not deteriorated. The collected royal jelly was immediately cooled with ice water, and when the royal jelly reached the temperature of the ice water (almost 0 ° C.), it was rapidly frozen to -5 to -20 ° C. to prevent deterioration,
It is carried into the factory. In a factory, frozen royal jelly is once naturally thawed, then freeze-dried at an ultra-low temperature of -30 to -40 ° C to remove moisture and to be pulverized.

Next, as a pretreatment for forming a tablet, an excipient and a lubricant are blended with royal jelly and mixed and stirred. Lactose is used as an excipient. In addition to lactose, crystalline cellulose and corn starch can also be used, and two or more of these may be used in combination. In addition, a vegetable hardened fat is blended with the lubricant. Hardened soybean oil and the like are suitable, but not limited thereto, and sucrose, sugar esters or fatty acid esters can also be used. Lubricants may be added together with excipients to obtain granules depending on their properties, or may be added during tableting.

The amount of the excipient is 150 to 180 parts by weight and the amount of the lubricant is 0.5 to 100 parts by weight of royal jelly.
Preferably, it is １．２1.2 parts by weight. If the amount is less than this range, the yield of tableting will be poor, and if it is too large, the ratio of nutrients will decrease, and the original purpose will not be achieved. As an auxiliary component, for example, by adding an appropriate amount of bone calcium powder, the calcium component can be strengthened. Further, catechin may be blended to prevent oxidation.

When heat is applied during mixing and stirring, the quality of royal jelly deteriorates. Therefore, while lowering the temperature, stirring is performed while reducing the humidity and ventilation drying until the tableting by the tableting machine becomes possible. Even if ventilation is performed at 40 ° C. due to low humidity, the temperature of the processed material is about 20 ° C. and is hardly affected by the temperature. The mixed and stirred raw material becomes granules suitable for tableting. Granule size is 100
A diameter range of ２０００2000 μm is preferred.

The tableting machine may be a general-purpose tableting machine generally used for tablet production in the pharmaceutical industry. For tableting, the above granular raw material is tableted at a humidity of 40% or less and a temperature of 25 ° C. or less, and the uncoated tablet is stored in a closed container containing a desiccant. The tablet size varies depending on the ratio of the royal jelly in the compounding ingredients, but is determined by the royal jelly content per tablet.

Next, the uncoated tablet produced by tableting is subjected to a treatment for imparting enteric properties in order to prevent decomposition of royal jelly by gastric juice. To make an uncoated tablet enteric-coated, its surface is coated with an alcohol-soluble protein alcohol solution extracted from cereals. As the grain, wheat, corn, soybean and the like are suitable.

For the formation of an enteric film, a solution extracted from a protein fraction of a grain (eg, wheat or corn gluten meal) with an alcohol is used.
The extract is used as a solution of a predetermined concentration after removing and purifying insoluble foreign substances by ordinary purification means such as filtration. 60 ~
A concentration of 5 to 10 parts by weight of the dissolved component (solid state) in 100 parts by weight of 90% alcohol is suitable. To improve familiarity with the shellac coating layer described below,
An appropriate amount (for example, an equal amount) of shellac can be dissolved and used at the same time. .

In order to improve the moisture resistance of the tablet, it is desirable to perform shellac coating before the enteric coating treatment. . Shellac is a natural resin secreted by lac radish parasitic on leguminous or mulberry plants from Southeast Asia, and is insoluble in water and soluble in alcohols and organic solvents. It is used as a glossing agent for western confectionery such as chocolate and as a coating agent for citrus fruits.

Shellac coating, uncoated tablet 60kg
After spraying a shellac solution (8 to 12% ethanol solution) at a rate of about 3.5 to 5 liters in 3 to 5 portions, the shelf-type dryer is used at 15 to 45 ° C for 15 hours or more dry. Coating thickness is 25-35μm
It is. An uncoated tablet coated with shellac has almost no air permeability, and the quality of the product is prevented from deteriorating due to moisture absorption in subsequent steps.

In order to form an enteric film on the tablet, the uncoated tablet is directly coated with shellac or after coating the uncoated tablet with a shellac coating, and then placed in a film coating pan (FM pan) to remove alcohol such as corn extracted from corn. 13 to 17 liters of an ethanol solution containing 3 to 6% of dissolved protein, 0.5 to 1% of glycerin fatty acid ester, and 3 to 6% of shellac as needed is used as a coating solution, and the air supply temperature is 50 to 60 ° C. Air volume 10-1
Film coating is performed for 4 to 6 hours under the conditions of ² m ³ / min, pan rotation speed of 8 to 10 times / min, and spray pressure of 3.5 to 5 kg / m ² . The coating thickness is 35-40
μm.

For tablets coated with an enteric coating, granulated sugar, gelatin, gum arabic, lactose,
Sugar coating is performed using a sugar coating material containing calcium calcium powder and catechin as necessary. The mixing ratio of the sugar coating material is as follows: granulated sugar 40-50%, gelatin 1-2%, gum arabic 1-2%, bone calcium powder 7-1 when added
1%, catechin 3-5%, lactose residue. There is no problem even if bone calcium powder and catechin are not used. After the sugar coating is put on the enteric film coating, it is humidified under a constant humidity condition, so that the crystal on the sugar coating surface is made dense to prevent cracking. If this humidification treatment is not performed, fine cracks may occur on the surface of the sugar coating layer.

Subsequently, the sugar coating layer is subjected to a glossing treatment.
Carnauba wax, for example, is used as a brightening agent.
Carnauba wax is a natural waxy substance obtained from the leaves of wax palm and is commonly used for brightening sweets. The luster disappears instantly when steamed, because it is a natural product. The sugar-coated tablet containing royal jelly thus completed has a moisture content of 0.5.
１1%, hardness is 15 kg or more.

[0022]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Embodiments of the present invention will be described, but the present invention is not limited thereto. Example 1 Coarse royal jelly collected at Sanken Wei Ri Bee Farm (Xinying Town, Tainan County, Taiwan, Taiwan) and kept in ice water (0 ° C.) for 2 to 3 hours immediately after collection to obtain ice water temperature -15 ° C. was used as a raw material. After the material was naturally thawed, it was freeze-dried in vacuum at -38 ° C and 150 hectopascals to obtain a powder. Particle size is 150-20
The range was 0 μm.

To 100 kg of the powder, 42 kg of lactose as an excipient and 0.8 kg of hardened soybean oil as a lubricant were mixed and sufficiently stirred at 25 ° C. or less and 60% or less humidity to obtain granules for tablet formation. The particle size of the granules is 1000-2000μ
m. Humidity 3 until the granules can be compressed
Air dried below 0%. The water content was 1%.

Tableting machine manufactured by Hata Seisakusho Co., Ltd. (Model D3)
550 under the condition of humidity of 60% and temperature of 25 ° C. or less.
235 mg / piece of uncoated tablet was produced at a rate of pieces / minute and stored in a sealed container containing a desiccant. The uncoated tablets were selected, and except for defective products, coated with an enteric coating. In order to make the uncoated tablet enteric-soluble, the surface of the tablet is alcohol-soluble corn protein 5% and glycerin fatty acid ester 0.
The coating is carried out using 24 liters of an alcohol solution containing 7%. For coating, put the uncoated tablet in a film coating pan (FM pan) and supply air at 56 ° C.
Film coating was performed for 5 hours under the conditions of an air volume of 11 m ³ / min, a pan rotation speed of 9.25 times / min, and a spray pressure of 4 kg / m ² . The coating thickness was 37 μm.

The tablets coated with the enteric coating are sugar-coated using 14 kg of a sugar coating material consisting of granulated sugar, gelatin, gum arabic and lactose. The mixing ratio of sugar coating material is 45% granulated sugar and 1.5% gelatin.
%, Gum arabic 1.5% and lactose residue. After the sugar coating is applied, the crystal on the surface of the sugar coating layer is made dense by humidification at a humidity of 95% to prevent cracks.

Next, the sugar coating layer is subjected to a glossing treatment using carnauba wax. The powder of carnauba wax is mixed and stirred, adhered to the surface of the sugar coating layer and waxed.
The finished dragee containing royal jelly weighs 450.
mg, 9 mm on a side, 7 mm in thickness, with a chamfered equilateral triangular shape. Each tablet contained 165 mg of royal jelly, 69.44 mg of lactose, and 0.56 mg of soybean oil and fat. The water content was 0.8% and the hardness was 15 kg or more. When the lock shape is round, the size is 11 mm in diameter and 7 mm in thickness.

Example 2 A tablet was produced under the same conditions as in Example 1 except that coating was performed by adding 5% of shellac to the enteric film forming solution.

Example 3 Royal jelly tablets were prepared in the same manner as in Example 1 or Example 2 except that a shellac coating step was added before coating the enteric film of Examples 1 and 2. . For shellac coating, 6.6 liters of a shellac solution (10% ethanol solution) is sprayed in three portions on 100 kg of uncoated tablets, and then dried at 40 ° C. for 15 hours or more by a shelf dryer. The coating thickness was 30 μm. The moisture content of the product is 0.5%, the hardness is more than 15kg,
Improved moisture resistance. In addition, in the case of the enteric coating of Example 1, some of the adhesive coating with the shellac coating was insufficient, but in the case of the enteric coating of Example 2, good results were obtained.

The sugar-coated tablets containing the royal jelly thus produced were subjected to characteristic tests. A disintegration test was performed using an artificial gastric fluid (first fluid) and an artificial intestinal fluid (second fluid) under the conditions specified in the General Pharmacopoeia General Test Method. In the first liquid, all six sugar-coated tablets containing royal jelly were 60
Did not dissolve for more than a minute. Subsequently, when the sample tested in the first liquid was immersed in the second liquid, one sample was taken after 22 minutes and 40 seconds, two pieces after 23 minutes, one piece after 24 minutes and 30 seconds, and one piece after 24 minutes and 40 seconds. After 20 minutes, the last one collapsed. As a result, it was confirmed that the royal jelly sugar-coated tablet of the present invention was not dissolved by gastric juice and had excellent enteric properties.

As a storage test, a temperature of 40 ° C. and a humidity of 75
%, And the change in water content and the change in the content of 10-hydroxy-δ-2-decenoic acid in royal jelly were examined. As a result, at the start of storage, the water content was 2.6% and the decenoic acid was 1.79%, but after 4 weeks, the water content was 2.6%, the decenoic acid was 1.59%, and after 8 weeks, the water content was 3.3. % And decenoic acid were 1.46%. Four weeks of the above conditions correspond to one year at room temperature, and eight weeks correspond to two years. From this result, it is clear that the royal jelly sugar-coated tablet of the present invention can maintain stable quality for a long period of time.

[0031]

The present invention is constituted as described above, and thus it is clear that royal jelly dragees are not dissolved by gastric juice, have excellent enteric properties, and can maintain stable quality for a long period of time. It has excellent effects and is extremely useful as a health food.

Claims (21)

[Claims] 1. An uncoated tablet comprising 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 glossy coating on the sugar coating layer. A royal jelly tablet in which quality deterioration is suppressed, characterized in that a release layer is formed. 2. Any one or a combination of lactose, crystalline cellulose, and corn starch as an excipient, and any one or a combination of vegetable hardened fats and oils, sucrose, a fatty acid ester, and a glycerin fatty acid ester as a lubricant. A royal jelly tablet according to claim 1, wherein the quality deterioration is suppressed. 3. The royal jelly tablet according to claim 1, wherein the enteric coating comprises only a coating layer formed by applying an alcohol-soluble protein alcohol solution extracted from cereals. 4. The quality control according to claim 1 or 2, wherein the enteric film comprises a coating layer formed by applying an alcohol solution of a mixture of an alcohol-soluble protein extracted from cereals and shellac. Royal jelly tablets. 5. The royal jelly tablet according to claim 1, wherein the cereal is one of wheat, corn, and soybean. 6. The royal jelly tablet as claimed in claim 1, wherein the royal jelly tablet is provided with a two-layer coating in which a shellac film is formed under an enteric film. 7. The royal jelly tablet according to claim 1, which is a sugar-coated layer formed of granulated sugar, gelatin, gum arabic and lactose. 8. The royal jelly tablet according to claim 1, wherein a densified sugar coating layer and a glossy layer are formed on the sugar coating layer. 9. The royal jelly tablet as claimed in claim 1, which is a glossy layer made of carnauba wax. 10. A granulated mixture formed by mixing and stirring a dry powder royal jelly, an excipient and a lubricant is dried to a tabletable state, and the granulated mixture is formed by tableting with a tableting machine. A method for producing a royal jelly tablet in which quality deterioration is suppressed, characterized in that after applying a coating process for imparting enteric properties to the surface of the uncoated tablet, sugar coating is applied, and the sugar coating layer is subjected to a glossing treatment. 11. The method according to claim 11, wherein the excipient is lactose, crystalline cellulose, or corn starch or a combination thereof, and the lubricant is any of vegetable hardened fats and oils, sucrose, fatty acid ester, glycerin fatty acid ester or a combination thereof. Item 1
0. A method for producing a royal jelly tablet in which quality deterioration is suppressed. 12. The method for producing a royal jelly tablet with suppressed quality deterioration according to claim 10 or 11, wherein the drying of the granulated mixture into a tabletable state is carried out by dehumidification at a low temperature. 13. A tableting machine using a tableting machine with a humidity of 40% or less;
The method is performed at a temperature of 20 ° C. or less.
A method for producing a royal jelly tablet wherein the quality deterioration described above is suppressed. 14. The coating according to any one of claims 10 to 13, wherein an enteric coating is formed by applying an alcohol-soluble protein alcohol solution extracted from cereals onto a tableted uncoated tablet. A method for producing a royal jelly tablet in which quality deterioration of a tablet is suppressed. 15. The coating as an enteric coating, wherein the coating is formed by applying an alcohol solution of a mixture of an alcohol-soluble protein extracted from cereals and shellac onto a tableted uncoated tablet. 13. The method for producing a royal jelly tablet according to any one of 13), wherein quality deterioration is suppressed. 16. The method for producing a royal jelly tablet according to claim 10, wherein the cereal is one of wheat, corn, and soybean. 17. The method for producing a royal jelly tablet according to claim 10, wherein a coating is formed using an alcoholic solution of shellac before forming the enteric film. 18. The sugar coating layer comprises granulated sugar, gelatin,
The method for producing a royal jelly tablet according to any one of claims 10 to 17, wherein the royal jelly tablet is formed of gum arabic and lactose and has suppressed quality deterioration. 19. The method for producing a royal jelly tablet in which quality deterioration is suppressed according to claim 10, wherein the sugar coating is densified under humidified conditions after the sugar coating. 20. The method for producing a royal jelly tablet in which quality deterioration is suppressed according to any one of claims 10 to 19, wherein a glossing treatment is performed on the dense sugar coating layer. 21. The method for producing a royal jelly tablet according to claim 10, wherein carnauba wax is used for glossing.