JPH09301877A - Agent for treatment and prevention of hepatitis - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an agent for the treatment and prevention of hepatitis by using powder of Lactobacillus brevis as a component. SOLUTION: Powder of Lactobacillus brevis prepared by the concentration. and freeze-drying of a cultured liquid of Lactobacillus brevis is used as a component of the agent. The bacterial cell powder can be produced by dissolving yeast extract, glucose, potassium dihydrogen phosphate, sodium hydrogen phosphate, sodium chloride, sodium hydroxide and defatted soybean extract liquid in water under heating, adding precipitated calcium carbonate, adjusting the pH, sterilizing with high-pressure steam, adding a seed of Lactobacillus brevis to the obtained medium, culturing the seed cell, concentrating or centrifugally separating the produced cells and freeze-drying the separated cells. The cells are prepared in the form of a preparation containing about 10<8> to 10<9> cells/g and administered by oral administration. An oral agent for the treatment and prevention of hepatitis C and free from side effect can be produced without using expensive interferon.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a therapeutic / preventive agent for hepatitis containing Lactobacillus brevis powder, and more particularly to a therapeutic / preventive agent for hepatitis C.

[0002]

2. Description of the Related Art Lactobacillus brevis is a kind of lactic acid bacterium found in the "pickled" pickles of Kyoto. In recent years, attention has been rapidly gathered as an immune function promoting agent that enhances interferon production and promotes immune function. For example, Japanese Patent Fair 7-
No. 55908 discloses an immune function-promoting agent containing Lactobacillus brevis powder.

In Japanese Patent Publication No. 55908/1995, administration of Lactobacillus brevis powder produces interferon α production, interferon γ production, NK activity, 2
It is stated that it will be useful for the treatment and prevention of infectious diseases and tumors because it enhances -5A activity and promotes immune function.

Although interferon has been administered to treat hepatitis, especially hepatitis C in recent years, it is extremely expensive, has many side effects, requires strict hospitalization, and has a low cure rate. Currently, there are various problems that cannot be dealt with adequately.

[0005]

[Problems to be Solved by the Invention] Focusing on that Lactobacillus brevis powder enhances interferon α production, interferon γ production, NK activity and 2-5A activity in the human body to promote immune function, hepatitis It is an object of the present invention to verify how effective a treatment can be and to clarify its effectiveness as a drug for treating or preventing hepatitis. It is also an object of the present invention to provide an oral therapeutic / preventive agent for hepatitis C, which is free from expensive interferon and has no side effects.

[0006]

According to the present invention, the above object is to concentrate a culture solution of Lactobacillus brevis.
This is achieved by a hepatitis treatment / prevention agent containing Lactobacillus brevis powder obtained by freeze-drying.

The hepatitis treatment / prevention agent of the present invention is characterized in that it contains Lactobacillus brevis bacteria powder, which can be produced, for example, as follows.

First, a medium having the following composition is prepared. Yeast extract 0.5% Glucose 1.5% Potassium dihydrogen phosphate 0.5% Sodium hydrogen phosphate 2.0% Sodium chloride 0.425% Sodium hydroxide 0.0375% Defatted soybean extract 8.75% Precipitation Calcium carbonate 0.1% (For defatted soybean extract, add defatted soybeans to an aqueous solution of about 0.25N hydrochloric acid, add pepsin and let stand at 37 ° C for 40-48 hours with occasional stirring to allow digestion. After the centrifugation, the supernatant is removed and used as a defatted soybean extract solution) is added to water to dissolve by heating, and the solution is adjusted to pH 6.8-7.0. Then, autoclave sterilization is performed at 121 ° C. for 15 minutes.

Next, Lactobacillus brevis (La)
ctobacillus brevis subsp.
Coagulans) inoculated into this medium,
18-4 while stirring at a speed of 100 rpm at 35 ° C
Incubate for 0 hour. After concentrating or centrifuging this solution,
Freeze-dried Lactobacillus brevis bacteria to about 2 x 1
0 ⁹ -5x10 ¹⁰ atoms / g including bacterial powder can be obtained.

The obtained bacterial powder has an appropriate number of bacteria, for example, 10
⁸ - 10 ⁹ cells / after the adjustment of the number of bacteria in such dispersing aid g about to become as potato starch, powders added excipients and the like,
Oral administration is preferably performed in the form of tablets, capsules, granules, liquids and the like. In the case of the tablet of the preferred embodiment, it is convenient to use, for example, a tablet containing about 5 × 10 ⁷ bacteria / tablet.

The inventors of the present invention have prepared a preparation containing this Lactobacillus brevis bacterium powder in an abnormally high GOT and GPT value, and for a patient diagnosed with hepatitis C as a result of close examination, 1
The daily dose equivalent to about 3 x 10 ⁸ bacteria was orally administered continuously, and the effects on GOT and GPT values, changes in symptoms, toxicity, etc. were verified, and in all patients, rapid decrease in GOT and GPT values and normal values were achieved. The results were good with recovery of symptoms, improvement of symptoms and no toxicity. Hereinafter, details of the present invention will be described with reference to examples.

[0012]

Example 1 Inoculum of Lactobacillus brevis was put in the above-mentioned medium and cultured at 25-35 ° C. with stirring at a speed of 100 rpm for 30 hours, and then about 10,000 rp.
After centrifugation at m, it was freeze-dried to obtain Lactobacillus brevis bacteria powder. The obtained bacterial powder is (1) Gram-positive bacilli, and (2) dissolved in calcium carbonate in the medium,
(3) Lactic acid is produced from glucose in the medium, (4) Nitrate reduction ability is negative, (5) Gelatin degradability is negative, (6)
The casein degradability was negative, and the glycodegradability was consistent with Lactobacillus brevis.

Dry potato starch was added to the bacterial powder, anhydrous lactose was added as an excipient, and the mixture was compressed into tablets to give 250 mg tablets (bacteria number: about 5 × 10 ⁷ ). Patient A 52 year old male Blood test results showed abnormally high GOT and GPT values, and hepatitis C was diagnosed by close examination, so interferon (6 million units-3 million units / piece x 102) at a medical institution The above-mentioned tablets were administered daily to 6 patients (bacterial count of about 3 x 10 ⁸ ) to a patient who had received no medication but showed no signs of recovery. The GPT value decreased. I had better bowel movements, a good complexion and less fatigue.

[Table 1]

[0014]

[Example 2] Patient B 42-year-old female For a patient suspected of hepatitis with abnormally high GOT and GPT values as a result of a blood test in a medical examination, 6 tablets of the above-mentioned daily dose (bacteria number about 3 x 10 ⁸⁾ was allowed to take, GOT as shown in Table 2, GPT value was reduced.
He had no side effects, improved bowel movements and sleeping, and no fatigue.

[Table 2]

[0015]

[Example 3] Patient C 34 year old male Patient C diagnosed with hepatitis C by blood donation at the Japanese Red Cross Society
In addition, the above-mentioned tablets were taken as a daily dose of 6 tablets (the number of bacteria was about 3 x 1
⁸ ) was taken, and as shown in Table 3, GOT, G
The PT value decreased. He had no side effects, had better bowel movements and did not catch a cold.

[Table 3]

[0016]

[Example 4] Patient D 63-year-old male Patient D, who was diagnosed with hepatitis C due to blood transfusion, was given 6 tablets (the number of bacteria was about 3 x 10 ⁸ ) as the daily dose. As shown in Table 4, GOT and GPT values decreased. He had no side effects and was in good physical condition.

[Table 4]

Claims (2)

[Claims] 1. A therapeutic / preventive agent for hepatitis containing Lactobacillus brevis bacterium powder obtained by concentrating and freeze-drying a culture of Lactobacillus brevis bacterium. 2. The hepatitis treatment / prevention agent according to claim 1, wherein the hepatitis is hepatitis C.