JPH04273823A - Bifidobacterium bacterium preparation and production thereof - Google Patents

Abstract

PURPOSE:To provide the subject preparation capable of surely transporting Bifidobacterium bacteria to a small intestine without killing the bacteria in a stomach when the preparation is orally administered, and resisting to the storage thereof for long periods. CONSTITUTION:A Bifidobacterium bacterium preparation comprises the powder of Bifidobacterium bacteria coated with an enteric coating material such as carboxymethyl cellulose or shellac. The Bifidobacterium bacterium preparation is produced by dissolving or dispersing an enteric coating material in a solvent, dispersing the powder of the Bifidobacterium bacterium cells in the solution or dispersion, and subsequently spray-drying the obtained dispersion; or dissolving or dispersing the enteric coating material in a solvent, feeding the solution or dispersion into a high speed gas flow, bringing the fed solution or dispersion into contact with the powder of the Bifidobacterium bacterium cells fed into the high speed gas flow to coat the powder of the bacterium cells with the enteric coating material, and subsequently drying the coated powder.

Description

[Detailed description of the invention]

0001

TECHNICAL FIELD The present invention relates to a Bifidobacterium preparation which is formed by coating the surface of Bifidobacterium powder, and a method for producing the same.

0002

[Prior Art] There has been a manufacturing method in which capsules with a diameter of 3 mm or less are filled with oil in which enteric bacteria such as Bifidobacterium are dispersed, and an enteric coating is applied on the coating material (Unexamined Japanese Patent Publication No. 1982-201823) and a method of coating bifidobacteria with oil that melts at body temperature in order to protect them from external factors such as oxygen (Japanese Patent Laid-Open No. 57-1999).
No. 33543) etc. have been proposed.

However, the method disclosed in JP-A No. 62-201823 requires special equipment and a lot of time and steps, and there is a possibility that bacteria may be killed by moisture in the capsule film, resulting in problems with storage stability. There is.

Furthermore, according to the method of JP-A No. 57-33543, since oils and fats that exhibit fluidity at temperatures above 35° C. are used, the oils and fats coating the bifidobacteria coated with oils become fluid before they reach the intestines. As a result, there is a problem that most of them are killed by gastric juice.

[0005]

[Problems to be Solved by the Invention] Many reports have been made regarding the physiological significance of Bifidobacterium, which shows that it suppresses the growth of Escherichia coli, Clostridium perfringens, Bacteroides, etc., which are the causative bacteria of intestinal putrefaction, and causes diarrhea and It is already known to have excellent physiological effects such as preventing constipation and producing organic acids such as lactic acid and acetic acid, and vitamins.

[0006] However, Bifidobacteria generally have poor survivability and tend to have reduced activity. In addition, the texture was poor due to the odor peculiar to bifidobacteria and the starch odor of the protective agent.

[0007] Bifidobacteria easily die in acidic solutions, and it is difficult for them to pass through the stomach, which has a pH of 1.2 to 5.0, and reach the intestines while maintaining their activity.

[0008]Therefore, there has been a need to find a means to ensure that bifidobacteria, which are useful for human health, reach the intestines without being killed in the stomach when administered orally.

[0009] Furthermore, when Bifidobacterium is used as a preparation, it is necessary to keep it alive for a long period of time, and therefore there is a need to develop a preparation that can be stored for a long period of time.

0010

[Means for Solving the Problems] As a result of intensive research to solve the above-mentioned problems, the present inventors have developed a bifidobacteria preparation by coating the surface of bifidobacteria powder with an enteric base material. They completed the present invention by discovering that Bifidobacterium can be stored for a long period of time, and that when administered orally, Bifidobacterium does not die in the stomach and can be ensured to reach the intestines in a viable state. .

That is, the present invention provides a bifidobacteria preparation comprising a powder of bifidobacteria cells whose surface is coated with an enteric base material.

The enteric base material used to coat the surface of the Bifidobacteria powder of the present invention has a film-forming property used in the technical field of pharmaceutical preparations, and when administered orally, the enteric base material has a film-forming property that is used in the technical field of pharmaceutical preparation. Specific examples include synthetic or semi-synthetic polymeric substances such as carboxymethylcellulose, hydroxymethylcellulose phthalate, and Eudragit, and natural substances such as shellac. be able to.

[0013] In order to coat the surface of the Bifidobacterium powder with these enteric substances, the enteric substance is dissolved or dispersed in a solvent, and the bacterial powder is added to the resulting solution or dispersion. This dispersion is sprayed by a spray drying method and simultaneously dried to coat the surface of the bifidobacteria powder with an enteric substance, or the enteric substance is dissolved or dispersed in a solvent, The obtained solution or dispersion is supplied through a nozzle into a high-speed air stream, and a bacterial powder is separately supplied through a nozzle into a high-speed air stream, and the enteric substance solution or dispersion and the bacterial cells are separated in the high-speed air stream. A method is used in which the surface of the bacterial powder is coated with an enteric substance by contacting the bacteria with a powder, and then dried, thereby obtaining a bacterial powder of Bifidobacterium whose surface is coated with a film of the enteric substance.

[0014] The solvent in which these enteric substances are dissolved or dispersed may vary depending on the enteric substance selected;
Water, alcohols such as methanol, ethanol, propanol, butanol, ketones such as acetone, methyl ethyl ketone, esters such as ethyl acetate, butyl acetate,
Ethers such as dimethyl ether, diethyl ether, and tetrahydrofuran, and hydrocarbons such as hexane and pentane can be used singly or in combination.

In any of the above methods, suitable plasticizers such as glycerin monofatty acid esters, castor oil, etc. can be added to the solution or dispersion of the enteric material, and the enteric material of the solution or dispersion can be added to the solution or dispersion of the enteric material. The concentration is 5
~50 (w/w)%, preferably 10-32 (w/w)
The concentration shall be approximately %.

[0016] The apparatus used to produce the bacterial powder whose surface is coated with an enteric base material by the above-mentioned spray drying method may be a conventional spray dryer. In addition, an example of an apparatus used for producing a target product by contacting bacterial cells with an enteric base solution or dispersion in a high-speed air flow and subsequent drying is Dispacoat R manufactured by Nisshin Engineering Co., Ltd. .

[0017] In order to protect the surface of the Bifidobacterium powder with a coating as described above, effective bacteria can be preserved for a long period of time due to the coating made of the enteric base material thus obtained. If possible and taken orally,
The effective bacteria can reach the intestines without reducing the number of viable bacteria during preparation. Furthermore, since the enteric base is directly coated on the effective bacterial powder, it is possible to improve oxidation stability and humidity resistance stability.

[0018] In the present invention, the Bifidobacterium used is a normal Bifidobacterium, and is Bifidobacterium longum (Bifidobacterium longum).
um), Bifidobacterium infantes (Bif
idobacterium infantis), Bifidobacterium adolescentes (Bifidoba
cterium adolescentis), Bifidobacterium breve (Bifidobacterium breve)
um Breve) etc.

Next, the present invention will be explained with reference to examples.

Example 1 Bifidobacterium longum (Bifidobacterium longum)
terium longum) starch powder (viable bacteria count 8.5
x109/g) was dispersed in a shellac solution (30% ethanol solution). This dispersion was spray-dried using a spray dryer (manufactured by Okawara Kakoki Co., Ltd.) model L-8,
A material containing bifidobacteria was obtained.

Example 2 Bifidobacterium longum (Bifidobacterium longum)
terium longum) starch powder (viable bacteria count 8.5
x109/g) was dispersed in a shellac solution (25% ethanol solution). This dispersion was operated in the same manner as in Example 1 to obtain a bifidobacteria-containing material.

Example 3 Bifidobacterium longum (Bifidobacterium longum)
terium longum) starch powder (viable bacteria count 9.1
x109/g) was dispersed in a shellac solution (25% ethanol solution). This dispersion was surface-modified using a powder surface modification device (manufactured by Nisshin Engineering Co., Ltd., model DC-08) to obtain a bifidobacteria-containing material.

Storage test ■ Humidity resistance test The bifidobacteria-containing material obtained in this example was kept open for 30 minutes.
The samples were stored at 75% RH for one week and the number of viable bacteria was measured. (Table 1)

[0024]

[Table 1]

[0025] Acid resistance test The bifidobacterium-containing material obtained in this example was subjected to an acid resistance test for 1 hour and 2 hours in the Japanese Pharmacopoeia 1st liquid (pH 1.2). (Table 2)

[0026]

[Table 2]

① Survival Test The bifidobacterium-containing material obtained in Example 1 was dispersed in glycerin fatty acid ester to produce soft capsules, and a survival test of the bacteria was conducted. (Table 3) A soft capsule film was prepared using 100 parts of gelatin, 35 parts of glycerin, and an appropriate amount of purified water.

[0028]

[Table 3]

Claims (3)

[Claims] 1. A Bifidobacteria preparation comprising a Bifidobacterium cell powder whose surface is coated with an enteric base material. [Claim 2] The method comprises dissolving or dispersing an enteric base material in a solvent, adding and dispersing Bifidobacterium cell powder to this solution or dispersion, and subjecting the obtained dispersion to spray drying. A method for producing a bifidobacteria preparation according to claim 1. 3. The enteric base material is dissolved or dispersed in a solvent, this solution or dispersion is supplied into a high-speed air stream, and the Bifidobacteria cell powder is separately supplied into this high-speed air stream. 2. The method for producing a Bifidobacterium preparation according to claim 1, which comprises contacting the Bifidobacterium powder to coat the surface of the Bifidobacterium powder with an enteric base material and drying it.