JP2001321094A - Method for producing lactic bacterium-containing royal jelly tablet - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a method for producing lactic bacterium-containing royal jelly tablets containing live bacteria of lactic bacterium, prevented from discoloring to brown or blackish brown through oxidation, and suppressed in quality deterioration caused by decomposition of the ingredients therein by gastric juice. SOLUTION: This method for producing lactic bacterium-containing royal jelly tablets comprises such processes that a granular mixture formed by mixing and stirring dry powdery royal jelly, live bacteria powder of lactic bacterium, a vehicle and a lubricant, is dried through dehumidification at low temperatures to a tablet-producible state, a coating is formed using a shellac alcohol solution on the surface of the green tablets made through compressing the resultant granular mixture with a tableting machine at <=40% relative humidity and <=20 deg.C, the resultant tablets are subjected to a coating process to give them enteric properties through coating an alcohol solution of a mixture of shellac and alcohol-soluble protein extracted from cereals followed by sugarcoating thereon, and then a densification treatment is done on the resultant sugarcoating film under a humidifying condition followed by subjecting the sugarcoating layer thus densified to polishing treatment. The royal jelly tablets thus produced are such ones as not to be dissolved by gastric juice, as to have excellent enteric properties, sustain a stable quality for a long period and also exhibit an excellent effect in the function to put the intestine in order.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

The present invention relates to a lactic acid bacterium containing live lactic acid bacteria, which is prevented from discoloring to brown or brown due to oxidation, and whose quality is suppressed from deteriorating due to decomposition of components contained in gastric juice. The present invention relates to a method for producing royal jelly tablets.

[0002]

2. Description of the Related Art A method for producing royal jelly tablets in which quality deterioration is prevented has been disclosed by the present inventor in Japanese Patent Application Laid-Open No. 10-19190.
No. 4: Japanese Patent No. 3047325 is proposed.

[0003] Royal jelly, which is useful for maintaining health, is used as a health food. However, when taken by a person with a sensitive constitution, rare cases of gastrointestinal bloating or diarrhea may be complained. On the other hand, lactic acid bacteria represented by Bifidobacteria are useful for maintaining health such as intestinal action, are commercially available as intestinal medicines in various forms such as tablets, powders or liquids, and are considered for effective functioning. It is being done in various ways. (For example, JP-A-3-7233, JP-A-4-
41434 and JP-A-11-139978).

[0004]

However, it is difficult for the lactic acid bacterium product to maintain the characteristics of a viable bacterial state for a long period of time, and although sufficient consideration has been given in the prior art, sufficient results have been obtained. It was not at the moment. The present invention solves the above-mentioned problems in the prior art, contains live lactic acid bacteria, has no deterioration in quality even when stored for a long time, suppresses the influence on sensitive constitution, and can be taken even when taken. An object of the present invention is to provide a method for producing royal jelly tablets without loss of nutritional value.

[0005]

Means for Solving the Problems In order to achieve the above object, the present inventors have made intensive studies and found that the treatment of royal jelly containing live lactic acid bacteria at a low humidity and a low temperature. In addition, the present inventors have found that it is effective to superimpose the raw material on the shellac film and apply an enteric film thereon so that the present invention is completed.

[0006] That is, the present invention based on the above-mentioned findings provides a dry powder royal jelly, a live bacterial powder of lactic acid bacteria,
The granulated mixture formed by mixing and stirring the excipient and the lubricant is dried by dehumidification at a low temperature to a state where tableting is possible, and the granular mixture is subjected to a humidity of 40% or less by a tableting machine.
On the surface of the uncoated tablet produced by tableting at a temperature of 20 ° C or less,
After forming a coating using an alcohol solution of shellac, an alcohol solution of a mixture of an alcohol-soluble protein extracted from grains and shellac is applied to give a coating process for imparting enteric properties, and then sugar coating is applied. The method of producing a royal jelly tablet containing lactic acid bacteria, which comprises subjecting the sugar-coated layer to a densification treatment under humidified conditions after sugar-coating, and further performing a glossing treatment on the sugar-coated layer. It is.

[0007]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The construction and operation of the present invention will be described.
An object of the present invention is to maintain the intestinal function by viable lactic acid bacteria and to prevent the quality of royal jelly as a health food from deteriorating. The reduction in quality is to prevent lactic acid bacteria activity from being reduced in the manufacturing process, prevent browning of tablets due to oxidation, prevent lactic acid bacterium activity from being reduced due to gastric juice, and prevent nutrient components from decomposing.

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 a main ingredient of the raw material used in the present invention, is collected one day earlier than a case where it is normally collected from a 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.

On the other hand, lactic acid bacteria are obtained by drying and pulverizing live bacteria obtained by culturing. Commercially available lactic acid bacteria mainly composed of viable bacteria such as bifidobacteria include bifidobacterium powder (trade name: bifilon-5) manufactured by Morinaga Milk Industry Co., Ltd.
0N) or a spore-forming lactic acid bacterium powder (trade name: Lacris-S) manufactured by Sankyo Co., Ltd., etc., but other lactic acid bacterium (Fecaris bacterium, Gasselli bacterium, etc.) can be used alone or in combination. Also, an activated natto powder, for example, an activated natto fungus manufactured by Meguro Research Institute (trade name: Natto Bacterial Powder I)
The combined use of I) (15 to 25% by weight of lactic acid bacteria) further enhances the effect of lactic acid bacteria. In addition to active natto, oligosaccharides have similar effects.

As a pretreatment for preparing the tablets from the raw materials prepared as described above, excipients and lubricants are added to royal jelly, live bacterium powder of lactic acid bacteria and, if necessary, active natto bacteria, oligosaccharides and the like. The ingredients are blended 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 proportion of each component used in the production of the granular mixture is 15 to 30 parts by weight of live bacterial powder of lactic acid bacteria, 140 to 180 parts by weight of an excipient, and 0 to 100 parts by weight of royal jelly. It is preferably from 0.5 to 1.2 parts by weight. If it is less than this range, the yield of tableting will be poor, and if it is too large, the proportion of nutrients and the number of lactic acid bacteria that exert an intestinal function 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, an appropriate amount of catechin may be blended to prevent oxidation.

When heat is applied during mixing and stirring, the activity of lactic acid bacteria and the quality of royal jelly deteriorate. Therefore, while lowering the temperature, stirring is performed while reducing the humidity and ventilation drying until the tableting by the tableting machine becomes possible. The temperature of the processed material is 20 even if the air is blown at 40 ° C due to low humidity.
It is about ° C and is hardly affected by temperature. The mixed and stirred raw material becomes granules suitable for tableting. The size of the granules is preferably in the range of 100 to 2000 μm.

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 20 ° C. or less, and the resulting uncoated tablet is stored in a closed container containing a desiccant. The tablet size varies depending on the ratio of royal jelly and lactic acid bacteria in the compounding material, and is determined by the content of royal jelly and lactic acid bacteria per tablet.

Next, the uncoated tablet manufactured by tableting is subjected to shellac coating before the enteric coating treatment in order to improve moisture resistance. 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.

Subsequently, in order to prevent degradation of royal jelly and decrease in activity of lactic acid bacteria by gastric juice, a treatment for imparting enteric properties is performed. To make an uncoated tablet enteric-coated, its surface is coated with an alcoholic solution of "Tzein" (trade name) as an alcohol-soluble protein product extracted from corn. Grain proteins such as wheat and soybeans other than corn can also be suitably used.

As described above, a solution extracted from a protein fraction of a grain (eg, wheat or corn gluten meal) with an alcohol is used for enteric coating formation. 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. A concentration of 5 to 10 parts by weight of a dissolved component (solid state) in 100 parts by weight of 60 to 90% alcohol is suitable.
In order to improve the compatibility with the shellac coating layer, an appropriate amount (for example, an equal amount) of shellac is dissolved and used at the same time.

In order to form an enteric film on a tablet, an uncoated tablet is shellac-coated, then put into a film-coating pan (FM pan), and an alcohol-soluble protein (trade name) extracted from a grain, for example, corn. : Zein) 13 to 17 liters of an ethanol solution containing 3 to 6%, glycerin fatty acid ester 0.5 to 1%, and shellac 3 to 6% is used as a coating solution.
Air supply temperature 50-60 ° C, air volume 10-12 m ³ / min, pan rotation speed 8-10 times / min, spray pressure 3.5-5 kg / min
performing 4-6 hours film coating under the conditions of m ^2. Its coating thickness is 35-40 μm.

The tablets coated with the enteric film are sugar-coated using a sugar coating material in which granulated sugar, gelatin, gum arabic, lactose and, if necessary, bone calcium powder and catechin are blended. The mixing ratio of the sugar coating material is 40-50% of granulated sugar, 1-2% of gelatin, 1-2% of gum arabic, and when added, 7-11% of bone calcium powder, 3-5% of catechin, and the balance of lactose. . 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 is not applied,
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]

EXAMPLES Examples of the present invention will be described specifically, but the present invention is not limited by these examples. 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.

With respect to 100 parts by weight of the dried powder royal jelly, 18 parts by weight of bifidobacterium powder (trade name "Bifiron-50N" manufactured by Morinaga Milk Co., Ltd.) was used. 8.4 parts by weight of trade name "Lacris-S"), 6 parts by weight of active natto fungus (trade name "Natto fungus powder II" manufactured by Meguro Research Institute Co., Ltd.), lactose 1 as an excipient
49.8 parts by weight, and 0.8 parts by weight of hardened soybean oil as a lubricant were mixed and sufficiently stirred at a temperature of 25 ° C. or less and a humidity of 60% or less,
Granules for tablet formation. The particle size of the granules is 1000 to 20
It was distributed within 00 μm. The granules were air-dried at a humidity of 30% or less until they could be compressed. The water content was 1%.

Tableting machine manufactured by Hata Seisakusho Co., Ltd. (Model D3)
550 at a humidity of 40% and a temperature of 20 ° 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 are selected, and shellac coating is performed except for defective products. Shellac coating is 6.6 per 100 kg of uncoated tablet.
1 liter of shellac solution (10% ethanol solution) was sprayed in three portions, and then 40
Dry at 15 ° C for at least 15 hours. Coating thickness is 30
μm. To make the uncoated tablets enteric-soluble, alcohol-soluble corn protein (trade name:
Zein) 5%, glycerin fatty acid ester 0.7%,
The coating is carried out using 24 liters of an alcohol solution containing 5% of shellac. For coating, put the uncoated tablets in a film coating pan (FM pan), supply air at 56 ° C., air flow 11 m ³ / min, pan rotation speed 9.25 times / min, spray pressure 4 kg / m ² for 5 hours. Coating was performed. 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.
Dragees containing the finished royal jelly weigh 470 m
g, a round shape having a diameter of 10 mm, and 166 mg of royal jelly, 30 mg of bifidobacterium powder, 14 mg of spore-forming lactic acid bacteria powder, 10 mg of natto bacteria powder, and lactose in one tablet.
It contained 5 mg and 1.5 mg of soybean oil and fat. The sugar coating layer contained 100 mg of granulated sugar, 3 mg of gelatin, 3 mg of gum arabic, and 114 mg of lactose.
The water content was 0.8% and the hardness was 15 kg or more.

The properties of the sugar-coated tablets containing royal jelly and lactic acid bacteria thus produced were tested. The artificial gastric juice (1st
Liquid) and an artificial intestinal fluid (second liquid). In the first liquid, all six sugar-coated tablets containing royal jelly and lactic acid bacteria did not dissolve for more than 60 minutes. Subsequently, when the sample tested with the first liquid was immersed in the second liquid, one specimen was taken after 22 minutes and 40 seconds, and two specimens were taken after 23 minutes and 24 specimens.
One after 30 minutes, one after 24 minutes and 40 seconds, 49 minutes and 20 minutes
Seconds later, the last one collapsed. As a result, it was confirmed that the royal jelly dragees containing live lactic acid bacteria of the present invention were not dissolved by gastric juice and had excellent enteric properties.

As a storage test, a temperature of 40 ° C. and a humidity of 75
% Lactic acid bacteria, its water content change, and 10 hydroxy-δ- in royal jelly.
The change in the content of 2-decenoic acid was examined. As a result, at the start of storage, water content was 2.6% and decenoic acid was 1.79%, but after 4 weeks, water content was 2.6% and decenoic acid was 1.59%.
%, After 8 weeks 3.3% water and 1.46% decenoic acid
It became. For 4 weeks under the above conditions, 8
A week is equivalent to two years. From these results, it is clear that the royal jelly dragees containing live lactic acid bacteria produced by the present invention can maintain stable quality for a long period of time.

The results of an investigation on the intestinal regulation effect of the addition of lactic acid bacteria are as follows. A questionnaire was given to five healthy healthy subjects, taking the lactic acid bacteria-containing royal jelly tablets obtained in the above example once a day for three weeks once a day, and one week before the intake and one week after the intake. Took. 1. Number of flights (times / week) As a result, the number of defecations was increased, and the effects of removing intestinal wastes and eliminating abdominal pain and bloating were confirmed.

2. Stool color (diarrhea) The yellow, yellow, ocher, brown, black, brown, grayish brown (constipation) yellow, yellow, yellow, and brown (constipation) colors were determined as normal colors, and the ratio of their appearance was examined. By taking the drug, the appearance rate of normal colors increased, the intestinal environment was improved, and the effect of relieving constipation and diarrhea was improved.

3. Form of stool (constipation) In six stages of rolling, ticking, banana, semi-milled, muddy, and watery (diarrhea), banana-shaped and semi-milled shapes are used as normal shapes, and the frequency of appearance is examined. Was.

As a result of taking the stool, it was found that the appearance rate of the stool having a normal shape was increased, and that there was an effect of regulating intestinal water content. 4. Smell of stool The ratio of the number of appearances of faint odors was examined in three stages: pale, normal, and strong. The number of subjects with a weak smell increased, and the effect of improving the intestinal environment and promoting the discharge of waste products was recognized.

5. Defecation feeling Refreshed, almost refreshed, especially none, there is a feeling that some stool remains, there is discomfort There are five levels of expression,
The expressions of the former three were regarded as normal or in a good state, and the appearance frequency ratio was examined. A decrease in the discomfort rate and an increase in the refreshing feeling were confirmed, and an improvement in the refreshing feeling due to an increase in the shape and the number of times was confirmed.

As described above, as a result of ingesting royal jelly tablets containing lactic acid bacteria obtained according to the present invention, the stool properties are clearly improved, the number of defecations is significantly increased, and the color and shape are improved.
The feeling of discomfort during defecation decreased, that is, the feeling of exhilaration increased and the stool smell tended to decrease, and gastrointestinal bloating and diarrhea of sensitive persons observed when ingesting royal jelly tablets containing no lactic acid bacteria were observed. Slight symptoms were also resolved, confirming that it is useful for maintaining health.

Example 2 The procedure of Example 1 was repeated except that the active natto fungus (trade name “Natto bacterium powder II” manufactured by Meguro Research Laboratories Co., Ltd.) was replaced with the same amount of lactose. To produce royal jelly tablets containing lactic acid bacteria. The product obtained in Example 2 had a tendency to delay the manifestation of the intestinal action compared to the product of Example 1, but the use result was not particularly different from that of Example 1. .

[0036]

As described above, the royal jelly dragees containing live lactic acid bacteria produced according to the present invention have excellent enteric properties without being dissolved by gastric juice and have stable quality for a long period of time. It is clear that it can be maintained, has an excellent effect on intestinal function, and is extremely useful as a dietary supplement.

Continued on the front page (51) Int.Cl. ⁷ Identification symbol FI Theme coat II (Reference) A61K 9/40 A61K 9/40 9/42 9/42 35/64 35/64 35/74 35/74 A 47/14 47/14 47/26 47/26 47/36 47/36 47/38 47/38 47/42 47/42 47/44 47/44 47/46 47/46 F-term (reference) 4B041 LD06 LE01 LE05 LH02 LH09 LH11 LK08 LK09 LK14 LK17 LK18 LK23 LK25 LK40 LK42 LP09 LP13 LP14 4C076 AA43 AA45 BB01 BB05 CC40 DD45C DD46C DD66A DD67C EE31A EE41H EE53C FF25 FF63 4C087 AA02 AA35 Z60A MC

Claims (6)

[Claims] 1. A granulated mixture formed by mixing and stirring dry powder royal jelly, live lactic acid bacteria powder, an excipient and a lubricant, is dried by dehumidification at a low temperature until it can be tableted, and the granulated mixture is dried. The mixture was tabletted with a tablet machine at a humidity of 40% or less and a temperature of 20 ° C. or less, and a coating was formed on the surface of the uncoated tablet using an alcoholic solution of shellac. After applying an alcoholic solution of a mixture of protein and shellac to give a coating process for imparting enteric properties, sugar coating is carried out, and after sugar coating, the sugar coating film is densified under humidified conditions, and the sugar coating is further applied. A method for producing a royal jelly tablet containing lactic acid bacteria, wherein the layer is subjected to a glossing treatment. 2. The lactic acid bacterium is a bifidobacterium and / or a spore-forming lactic acid bacterium powder, and the excipient is lactose, crystalline cellulose, corn starch, or any combination thereof.
The method for producing royal jelly tablets containing lactic acid bacteria according to claim 1, wherein the lubricant is any one of vegetable hardened fats and oils, sucrose, fatty acid esters, and glycerin fatty acid esters or a combination thereof. 3. The method for producing royal jelly tablets containing lactic acid bacteria according to claim 1 or 2, wherein an active natto powder and / or an oligosaccharide are used in combination. 4. The method for producing royal jelly tablets containing lactic acid bacteria according to claim 1, wherein the cereal is any of wheat, corn and soybean. 5. The method for producing a royal jelly tablet containing lactic acid bacteria according to claim 1, wherein the sugar-coating layer is formed of granulated sugar, gelatin, gum arabic and lactose. 6. The method for producing a royal jelly tablet containing lactic acid bacteria according to claim 1, wherein carnauba wax is used for polishing.