JP2002308793A - Medicinal composition for therapy of tumor and health food - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medicinal composition for prevention/therapy of tumor and a health food. SOLUTION: This medicinal composition for prevention/therapy of tumor and the health food includes pot ale of Shotyu (spirits) as an active constituent.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

TECHNICAL FIELD The present invention relates to a pharmaceutical composition and a health food which enable prevention or treatment of tumors, for example, cancer, particularly gastric cancer, by using distilled spirits from shochu.

[0002]

2. Description of the Related Art Shochu is a distilled spirit unique to Japan that is proud of the world. The continuous distillation method is called shochu shellfish (white liquor), and the simple distillation method is shochu liquor (genuine shochu). We call and classify. When producing shochu, both remain at the bottom of the distillation still at the end of distillation, and this is called shochu distillation lees (also called shochu lees or distillation waste liquid). In the case of real shochu, citric acid, protein, fat, Contains fiber and trace amounts of nutrients. In addition, distilled spirits of shochu are characterized by the fact that non-volatile components are concentrated and the filterability is very poor (Yoshi Furusawa, Sake no Kagaku, Asakura Shoten, 1995, 6
0 page).

[0003] At present, there is a problem in the treatment and disposal of shochu distillation lees. The London Treaty (Treaty on the Prevention of Marine Pollution through Waste Disposal) has banned the introduction of industrial waste into the sea since 2001, and it has become impossible to use the generally used shochu distillation lees in the sea. If a low-cost disposal method alternative to ocean input cannot be found in the future, for example, in Kyushu alone, there is a concern that small-scale manufacturers, which are the majority of more than 300 shochu manufacturers, will be forced out of business.

[0004] From the above, in the shochu industry, there is a long-awaited need for the effective use of shochu distilled lees and the development of a processing method. For example, Japanese Patent Application Laid-Open No. 8-56884 discloses the production of feed obtained from shochu distilled lees. The method is shown. JP-A-10-130121 discloses a cosmetic comprising a fermentation product of distilled spirits from shochu. JP-A-2000-19
No. 8983 discloses a method for producing a porous carbonized material using liquor waste. In addition, many technological developments relating to the treatment of distilled shochu lees have been made before the present invention. However, there have been no studies on the prevention and treatment of shochu distilled lees for cancer so far, and no pharmaceutical composition or health food using the same has been known at all.

[0005]

SUMMARY OF THE INVENTION It is a first object of the present invention to provide a pharmaceutical composition for preventing and treating tumors containing distilled spirits of shochu as an active ingredient. The second object of the present invention is a health food containing shochu distilled lees as an active ingredient, in particular,
An object of the present invention is to provide a health food having an effect of preventing and treating tumors.

[0006]

Means for Solving the Problems The present inventors have paid attention to shochu distilled lees, and surprisingly, shochu distilled lees are tumors, for example,
The present inventors have found that the compound acts as a preventive / therapeutic component for cancer, particularly gastric cancer, and have obtained a new finding that the compound can be used as an unprecedented pharmaceutical composition or health food, thereby completing the present invention.
That is, the present invention provides a pharmaceutical composition for preventing or treating tumors, comprising shochu distilled lees as an active ingredient. The present invention also provides a health food characterized by containing distilled spirits from shochu.

[0007]

BEST MODE FOR CARRYING OUT THE INVENTION The shochu distilled lees referred to in the present invention are not particularly limited. For example, any conventional shochu distilled lees such as potato shochu distillate, sweet potato shochu distillate and barley shochu distillate can be used. Can be used. Shochu distilled lees can be easily obtained from a shochu manufacturing process as shown in FIG. 1, for example. Specifically, as a raw material, cereals such as sweet potato, sweet potato, barley (barley, wheat, etc.), buckwheat, rice, etc. are steamed and crushed, and a separately prepared primary moromi is added to prepare a secondary moromi, This is fermented at room temperature or the like, and then distilled, and the distillate is collected as a product, shochu, and the residue collected at the bottom of the still is distillation shochu, that is, shochu distillation shoal.
The primary moromi is prepared by adding shochu yeast and water to koji and then fermenting at room temperature or the like.

[0008] Therefore, distilled lees, ie, shochu distilled lees,
Fibers, proteins, ash, fats, sugars that remain partially unfermented, fermentation products, koji mold and yeast cells, and the citrates produced by them, derived from cereals such as sweet potatoes derived from raw materials other than ethanol Organic acids mainly composed of acids, amino acids, vitamins, etc., and various components formed by denaturation, polymerization or cleavage during fermentation or heating are included. For example, sweet potato shochu distilled lees contains about 5.45% by weight of dry solids, which are about 1.46% by weight of total sugar and about 0.4% by weight of straight sugar.
19% by weight, crude fat about 0.21% by weight, crude protein about 1.15
%, Crude fiber about 0.42% by weight, organic matter about 5.00% by weight, alcohol about 0.2% by weight, crude ash about 0.45% by weight, Na about 140ppm, K about 2250ppm, Ca about 220ppm, Mg About 120 ppm, Fe about 10 ppm
Etc., and the TOC is about 206000 to about 23
7000, TN is about 1700 to about 23000, BOD is about 48900, and COD is about 30100. The supernatant obtained by centrifuging the sweet potato shochu distilled lees contains about 2.43 to about 2.74% by weight of dry solids, which are about 0.77% by weight of total sugar and about 0.77% by weight of straight sugar. 1.23% by weight, crude protein about 0.44% by weight, organic matter about 2.27% by weight, alcohol about 0.2% by weight, crude ash about 0.35 to about 0.47% by weight, N
a about 150 ppm, K about 2380 ppm, Ca about 6.3
ppm, about 103 ppm of Mg, about 3.2 ppm of Fe, etc., and the TOC is about 11100 to about 1170.
0, TN is about 640 to about 1000, BOD is about 3010
0, COD is about 17,600 ("brewery ingredients")
Japan Brewery Association, December 1999, page 139-1
Section 41, page 41, section IX "Distillation waste liquid components"). The composition of distilled spirits from wheat shochu is described on page 4 of JP-A-10-229825.

In the present invention, such distilled spirits of shochu can be used as they are, but it is preferable to use a supernatant obtained by centrifugation. Centrifugation can be performed by a conventional method. In the present invention, the distilled spirits of shochu may be used as they are, or the supernatant obtained by centrifugation thereof may be dried. The drying method may be any commonly known drying method, and preferably, an industrially available method such as spray drying or freeze drying is used.

The distilled shochu lees used in the present invention can be used as it is as a pharmaceutical composition or health food, or provided as a pharmaceutical composition or health food after processing such as freeze-drying and sterilization, thereby obtaining cells such as tumors. It works effectively for prevention or treatment of proliferative diseases. Also, when provided as an essential component in a conventionally known pharmaceutical composition or health food, it works effectively for the prevention or treatment of cell proliferative diseases such as tumors. The tumor as referred to in the present invention is, for example, hematopoietic cancer such as acute leukemia, chronic leukemia, malignant lymphoma, multiple myeloma, macroglobulinemia, brain tumor, head and neck cancer, breast cancer, lung cancer, esophageal cancer, gastric cancer, large intestine Cancer, liver cancer, gallbladder
Bile duct cancer, pancreatic cancer, pancreatic islet cell carcinoma, renal cell carcinoma, adrenal cortex cancer, bladder cancer, prostate cancer, testicular tumor, ovarian cancer, uterine cancer, choriocarcinoma,
Tumors that form solid tumors such as thyroid cancer, malignant carcinoid tumors, skin cancer, malignant melanoma, osteosarcoma, soft tissue sarcoma, neuroblastoma, Wilms tumor, fetal rhabdomyosarcoma, retinoblastoma, or It is a cancer disease derived and related to them. The shochu distilled lees of the present invention, tumors that can be prevented and treated by acting as an active ingredient are not limited to the above-mentioned cancers, and pharmaceutical compositions and health foods containing shochu distilled lees are used orally. If the target tumor disease is
It is particularly effective in preventing and treating gastric cancer.

The distilled shochu lees used in the present invention are mixed with known pharmacologically acceptable carriers, excipients, disintegrators, correctors, extenders, diluents, solubilizing agents, etc. According to the above method. However,
When shochu distillation lees are orally administered, the shochu distillation lees should be blended in an amount of 2% by weight or more, preferably 5% by weight or more, particularly 5 to 20% by weight based on the whole pharmaceutical composition. Pharmaceutical compositions of the present invention, for example, tablets, capsules,
It can be formulated into granules, powders, powders, pills, solvents, drinks, injections, drops, suppositories and the like. Such formulations can be administered orally or parenterally.

When the pharmaceutical composition of the present invention is used for the prevention or treatment of tumors, etc., the dosage varies depending on the administration subject, administration route, symptoms and the like. Daily dose of 50 mg / day to 500
It is preferable to administer about 1 to 3 times a day so as to obtain g / day. As a result, a remarkable preventive / therapeutic effect can be obtained for tumors, particularly gastric cancer. In addition, when the pharmaceutical composition is parenterally administered as an injection or a drip, the shochu distilled lees appropriately treated may optionally be contained in a molecular assembly for administration. Examples of molecular aggregates containing shochu distillation lees include fat emulsions, polymeric micelles, complexes with proteins such as albumin, liposomes, and the like, but liposomes are the most preferred in terms of safety and the like. No.

For example, a liposome solution containing shochu distillation lees may be formed by any known method.
For example, known production methods such as a thin film method, a reverse phase evaporation method, a freeze-thaw method, an ethanol injection method, a high-pressure emulsification method, an ultrasonic dispersion method, a dialysis method, and an extrusion method can be appropriately used. The method described in JP-A-9-87168 may be used. The liposome solution containing distilled spirits obtained in this manner may be purified by a method such as ultrafiltration, centrifugation, gel filtration, or the like, and operations such as concentration and dilution may be performed freely. And can be used as a pharmaceutical composition. When the pharmaceutical composition of the present invention is administered to the blood in the form of an injection or an infusion, the amount of distilled shochu distilled lees as one dose is one.
A solution containing a concentration of × 10-1 to 1 × 10 −6 M in 0.0
1 to 100 ml / kg body weight, preferably 5 shochu distilled lees
A solution containing a concentration of × 10−2 to 5 × 10−4 M is 1 to 5
The dose is preferably about 1 to 3 times a day at 0 ml / kg body weight.

The distilled spirits of shochu used in the present invention are mixed with known ingredients such as food acceptable foods, preservatives, thickeners, coloring agents, antioxidants, additives, seasonings and the like. ,
It can be made into a health food according to a known method. The health food referred to in the present invention may be shochu distilled lees itself having the effect of preventing or treating cancer in the present invention, but preferably the conventionally known food or health food, the shochu distilled lees in the present invention. It is made by blending. However, when ingesting shochu distilled lees, shochu distilled lees should be 2% by weight or more, preferably 5% by weight or more, based on the whole health food.
In particular, it is preferable that the content is 5 to 10% by weight.

[0015] Healthy foods can be prepared by conventional methods such as tablets, soft capsules, hard capsules, granules, solids, powders, powders, pills, solvents, chewables, drinks, dressings, confectionery and the like. Can be manufactured in form. In addition, without being limited to these forms, the health food of the present invention can be processed and processed into a general food form.
You may mix and provide. Such health foods include, for example, normal foods such as tempura, okonomiyaki, takoyaki, grilled potatoes, college potatoes, processed meat, oden, hamburgers, meat buns, gyoza, hot dogs, sandwiches, curry, hayashi rice, laver, pickles, kimchi, etc. Of course, tea, coffee, cocoa, vegetable juice, green juice, miso soup,
Liquid foods and drinks such as soups, and those that can add and blend shochu distilled lees in the present invention, noodles such as udon, fried noodles, soba, ramen, bread, biscuits, pasta, macaroni, processed rice, processed beans, Starch foods such as rice crackers, sweets such as candy, gum, chocolate, cake, short cream, ice cream, Japanese sweets, dairy products such as processed milk and yogurt, soy sauce, sauces, vinegar, chili oil, tabasco, western style dressing It can be used for any foods and drinks such as seasoning such as Japanese dressing, blue dressing, miso, nyokumum and mayonnaise.

The distilled spirits of shochu may be appropriately blended at an appropriate stage of the production process according to the characteristics and purpose of each food or food or drink. When the health food of the present invention is provided, it is provided that the shochu distilled lees is added to the food or food or beverage as a whole in an amount of 2% by weight or more, preferably 10% by weight or more.
Preferred from the point of treatment. The form of the health food of the present invention is not limited to these embodiments, and the production method is not limited,
To give a specific example, distilled shochu distillation lees are 5-30.
Parts by weight (hereinafter abbreviated as “parts”), 5 to 3 parts of edible refined fish oil
0 parts, brewed vinegar 5-25 parts, fructose glucose liquid sugar 5-15
Parts, 0.5 to 5 parts of salt, 0.2 to 3 parts of sugar, 0.1 to 2 parts of xanthan gum, 0.1 to 2 parts of sodium glutamate,
Spices 0.05-3 parts, water 20-50 as balance
Parts as raw materials and mixing according to a conventional method to form a dressing. Also, 5-150 parts of shochu distilled lees,
20-60 parts of cocoa mass, 20-60 cocoa butter
Parts, 70 to 110 parts of sugar, 1 to 5 parts of milk and 3 to 20 parts of shortening as raw materials, and can be made into chocolate according to a conventional method. In addition, distilled shochu distillation lees are 10 to 50.
0 parts, flour 100-600 parts, sugar 50-350 parts,
50 to 300 parts of margarine, 20 to 100 parts of whole egg powder, 0.5 to 8 parts of vanilla essence, and 70 to 250 parts of water can be added as raw materials to make a cookie according to a conventional method.
In addition, shochu distilled lees 0.1-8 parts, cocoa powder 0.5-
8 parts, sugar 0.5-8 parts, skim milk powder 0.1-3 parts, emulsifier 0.05-2 parts, salt 0.01-0.5 parts, vanilla flavor 0.01-0.5 parts, treatment 70-150 parts of water is added as a raw material, and a cocoa beverage can be obtained according to a conventional method.

Since the health food of the present invention is nontoxic to the human body, there is no particular restriction on the amount of the health food.
It is preferable to ingest about 1 to 3 times a day so that the daily intake is 1 to 1000 mg / kg body weight / day. This allows
A remarkable preventive / therapeutic effect is obtained for cancer, especially for gastric cancer.

EFFECT OF THE INVENTION The pharmaceutical composition and health food containing shochu distilled spirits of the present invention as an active ingredient are safe without side effects, and are extremely effective in preventing or treating tumors, especially gastric cancer.

[0018]

The present invention will be described in more detail with reference to the following examples and reference examples, but the present invention is not limited to these examples. Example 1 <Test for inhibiting growth of tumor cells using distilled spirits from potato shochu> 1-1. Preparation of freeze-dried substance of potato shochu distilled lees 25.92 g of potato shochu distilled lees obtained from Dr. Haruyuki Ieto, National Tax Agency Brewing Research Institute Environmental Conservation Laboratory, freeze-dried supernatant, and 0.889 g of potato A freeze-dried shochu distilled cake was obtained. The infrared absorption spectrum of the obtained lyophilized substance and the ultraviolet absorption spectrum of the supernatant are shown in FIGS. 2 and 3, respectively.

1-2. Description of Cells Used and Culture Medium Human lung adenocarcinoma cells (RERF-LC-OK) were purchased from the National Institute of Health. Human gastric cancer cells (GT3TKB) and human liver cancer cells (Hep-G
2) used was purchased from RIKEN Cell Development Bank. Mouse-derived malignant melanoma cells (B16-mel
Anoma) used was purchased from Dainippon Pharmaceutical. As a culture medium, human lung adenocarcinoma cells (RERF-
LC-OK) includes RPMI-1640 (+ 10% FB
S) was added to human gastric cancer cells (GT3TKB), human liver cancer cells (Hep-G2) and mouse-derived malignant melanoma cells (B16-melanoma) by DME-M (+
10% FBS) was used as a culture medium and used for a growth inhibition test.

1-3. Preparation of test sample Dissolve the freeze-dried material of distilled spirits from sweet potato shochu prepared in 1-1 in 29 times (corresponding to the volume of the stock solution before freeze-drying) PBS (-) [where PBS is a phosphate buffer] I let it. The concentration was 34.5 mg / ml. After dissolution, the obtained liquid was subjected to filtration sterilization treatment with a filter having a pore size of 0.45 μm to obtain a test sample.

1-4. Growth Inhibition Test The growth inhibition test is an enzyme activity measurement method, WST-1a.
This was performed by the ssay method. Tetrazolium salt WST-1
WST-1 assay method using WST-
This is a method for measuring cell proliferation activity by color development with one metabolite. The principle is that WST-1 is a good substrate for intracellular mitochondrial dehydrogenase, and the higher the viability of cells, the greater the amount of WST-1 that is degraded, and the resulting amount of formazan corresponds well to the number of viable cells Based on For each cell shown in 1-2, the initial cell number was 1.
Cell suspension 10 prepared at 0 × 10 ⁴ Cells / ml
0 μl / well was seeded on a 96-well multiplate, and after 24 hours of pre-incubation, the test sample obtained in 1-3 was added at 10 μl / well. 37
After culturing for 48 hours or 72 hours under the conditions of C., CO ₂ concentration of 5% and humidity of 95%, the WST-1 solution was added at 10 μl / we.
11 was added. After further culturing for 3 hours, a spectrophotometer (Mol
The absorbance at 450 nm was measured using an optical device. The cell growth inhibitory effect was measured by the absorbance (A) when PBS (-) was added as a negative control.
_Control ) and the ratio of the absorbance (A _Mean ) when the test sample is added (A _Mean / A
_Control ) was calculated and evaluated.

1-5. Results The effect of freeze-dried distilled syrup of potato shochu on the cell growth of various tumor cells was examined. The results are shown in FIG.

[0023]

[Table 1]

48 hours after the addition of the test sample, the growth inhibitory effect on human liver cancer cells (Hep-G2) was as follows:
Almost 70% of mouse-derived malignant melanoma cells (B16-melanoma) and human lung adenocarcinoma cells (RERF-LC-OK)
About 80% for human gastric cancer cells (GT3TKB),
It was observed that cell growth was suppressed. At 72 hours after the addition of the test sample, human liver cancer cells (Hep-
G2) also shows a slight growth inhibitory effect, and furthermore, mouse-derived malignant melanoma cells (B16-melanoma)
In human lung adenocarcinoma cells (RERF-LC-OK), the proliferation of cells was suppressed by about 60%, and human gastric cancer cells (G
T3TKB), a growth inhibitory effect as high as about 90% was observed.

Example 2 <Test for inhibiting the growth of tumor cells using distilled spirits from wheat shochu> 2-1. Preparation of freeze-dried substance of wheat shochu distilled lees 26.65 g of wheat shochu distilled lees obtained from Dr. Haruyuki Ieto, National Institute of Brewing Research Institute of Environmental Conservation, centrifuged, and lyophilized the supernatant to obtain 3.518 g of wheat A freeze-dried shochu distilled cake was obtained. The infrared absorption spectrum of the obtained lyophilized substance and the ultraviolet absorption spectrum of the supernatant are shown in FIGS. 5 and 6, respectively.

2-2. Description of Cells Used and Culture Medium The cells used and the medium used were the same as those used in Example 1-2.

2-3. Preparation of test sample The freeze-dried material of distilled spirits from wheat shochu prepared in 2-1 was dissolved in 6.5 times (corresponding to the volume of the stock solution before freeze-drying) PBS (-). The concentration was 150 mg / ml. After dissolution, the obtained liquid was subjected to filtration sterilization treatment with a filter having a pore size of 0.45 μm to obtain a test sample.

2-4. Growth Inhibition Test The growth inhibition test was performed except that the cells shown in 2-2 were used as cells and the test sample shown in 2-3 was used instead of the test sample shown in 1-3 as a test sample. The test was performed in the same manner as in the growth inhibition test shown in 1-4 of Example 1.

2-5. Results The cell growth inhibitory effect of freeze-dried barley shochu distilled lees on various tumor cells was examined. The results are shown in FIG.

[0030]

[Table 2]

As is clear from FIG. 7, a remarkable cell growth inhibitory effect of 90% or more was observed for all the tumor cells used. Example 3 <Test for inhibiting growth of tumor cells using distilled spirits from rice shochu> 3-1. Preparation of freeze-dried substance of rice shochu distilled lees 25.67 g of rice shochu distilled lees obtained from Dr. Haruyuki Ieto, National Institute of Brewing Research Institute of Environmental Conservation, centrifuged, and the supernatant was freeze-dried to obtain 0.86 g of rice. A freeze-dried shochu distilled cake was obtained. 8 and 9 show the infrared absorption spectrum of the obtained lyophilized substance and the ultraviolet absorption spectrum of the supernatant, respectively.

3-2. Description of Cells Used and Culture Medium Human lung adenocarcinoma cells (RERF-LC-OK) were purchased from the National Institute of Health. Human gastric cancer cells (GT3TKB) and human liver cancer cells (Hep-
G2) used was purchased from RIKEN Cell Development Bank. The medium used was the same as that used in Example 1-2.

3-3. Preparation of test sample The freeze-dried substance of rice shochu distilled cake prepared in 3-1 was 28.7.
Double volume (equivalent to the volume of the stock solution before freeze-drying) of PBS (-)
Was dissolved. The concentration was 34.7 mg / ml. After dissolution, the obtained liquid was subjected to filtration sterilization treatment with a filter having a pore size of 0.45 μm to obtain a test sample.

3-4. Proliferation inhibition test The proliferation inhibition test was performed except that the cells shown in 3-2 were used as cells and the test sample shown in 3-3 was used instead of the test sample shown in 1-3 as a test sample. The test was performed in the same manner as in the growth inhibition test shown in 1-4 of Example 1.

3-5. Results The effect of freeze-dried distilled spirits of rice shochu on various tumor cells was examined. FIG. 10 and Table 3 show the results.
It was shown to.

[0036]

[Table 3]

As is apparent from FIG. 10, a remarkable cell growth inhibitory effect of 90% or more was observed on human gastric cancer cells and human lung adenocarcinoma cells. These results suggest that shochu distilled lees such as potato shochu distilled lees and barley shochu distilled lees have therapeutic and preventive effects on cancer.

Reference Example <Single dose toxicity test of distilled spirits from shochu to normal rats>
In order to confirm the safety of distilled spirits used in the present invention as foods and pharmaceuticals, a toxicity test was performed using normal rats. Is shown. (Test sample preparation) The potato shochu distilled cake freeze-dried substance was 29 times the amount of PBS (-), and the barley shochu distilled cake freeze-dried substance was 6.5.
It was dissolved in twice the volume of PBS (-) (corresponding to the stock solution concentration). The concentration was 34.5 mg / m for freeze-dried shochu distilled lees.
1, the freeze-dried material of distilled spirits from wheat shochu is 150 mg / ml. After dissolution, a filter sterilized with a 0.45 μm filter was used.

(Test Method) Animal experiments were conducted at a facility of Kudo Co., Ltd. Normal rats were randomly divided into groups of four rats each, and a single dose toxicity test of distilled spirits from shochu was performed. The administration method was oral administration and intravenous injection. The dose is 15ml
/ Kg, and the whole amount was administered orally and via the tail vein in about 3 minutes. During the experimental period, general condition observation and body weight measurement were performed daily after the start of administration. Six days after the administration, all the subjects were fasted for about 19 hours, and then incised under ether anesthesia. Then, blood was collected from the abdominal vena cava.
After standing for 0 minutes, the mixture was centrifuged at 3000 rpm for 15 minutes, and the obtained serum was subjected to albumin, ALP activity, urea nitrogen, creatinine using a biochemical automatic analyzer (Fuji Dry Chem 3500V, manufactured by Fuji Film Co., Ltd.). , Glucose, GOT / AST activity, GPT / ALT activity, total bilirubic acid, total cholesterol, neutral fat, and total protein were measured. After collecting blood from all animals, the animals were dissected and macroscopic observations of various organs were performed. After necropsy, the liver, thymus, heart, kidney, lung, and spleen were excised, the organ weight was measured, and the organ weight was calculated based on the weight on the day.

The representative instruments used in this experiment are described below for reference. 1. Biochemical Automatic Analyzer Fuji Dry Chem 3500V
(Trade name, Fuji Film Co., Ltd.) Nicipet Ex (1000μ) (Trade name, Nichiryo) Fuji Dry Chem Clean Chip (Trade Name, Fuji Film Co., Ltd.) Fuji Dry Chem Slide ALB-P (Trade Name, Fuji Film Co., Ltd.) Fuji Dry Chem Slide ALP-P (trade name, manufactured by Fuji Film Co., Ltd.) Fuji Dry Chem Slide BUN-P (trade name, manufactured by Fuji Film Co., Ltd.) Fuji Dry Chem Slide CRE-P (trade name, manufactured by Fuji Film Co., Ltd.) Fuji Dry Chem Slide GLU-P (trade name, manufactured by Fuji Film Co., Ltd.) Fuji Dry Chem Slide GOT / AST-P (trade name, manufactured by Fuji Film Co., Ltd.) Fuji Dry Chem Slide GPT / ALT-P (trade name, manufactured by Fuji Film Co., Ltd.) ) Fuji Dry Chemsly TBIL-P (trade name, Fuji Photo Film Co., Ltd.) FUJI DRI-CHEM slide TCHO-P (trade name, Fuji Photo Film Co., Ltd.) FUJI DRI-CHEM slide TG-P (trade name, Fuji Photo Film Co., Ltd.) 14. Fuji Dry Chem Slide TP-P (trade name, manufactured by Fuji Film Co., Ltd.)

(Results) A single dose toxicity test of the freeze-dried substance of distilled spirits from shochu to normal rats was examined. The sample concentration was set to the concentration equivalent to the stock solution. As a result of observing the general condition of the rats for one week immediately after the administration, no abnormal symptoms or deaths were observed in any of the administration groups, and the body weight measurement (FIG. 11) showed that the control group and the sample administration group showed no abnormal symptoms or death. No significant difference was found between further,
From the macroscopic observation after dissection, no abnormal findings were found in all organs. After necropsy, the heart, thymus, kidney, liver, spleen, and lungs were excised, the organ weight was measured, and the body weight ratio organ weight (organ weight per 100 g rat body weight) was calculated based on the body weight on the day. The results are shown in FIGS. As is clear from the figure, no significant difference in body weight ratio organ weight was observed between the control group and the administration group.
It should be noted here that the kidney, which is said to be frequently injured because it becomes the first target organ when administered intravenously, and the liver, which is susceptible to drug damage when administered orally,
No effect of administration was observed. Next, a biochemical test was performed using serum obtained by centrifuging the collected blood. The results are shown in FIGS. As is clear from the figure, no significant difference was observed between the control group and the sample administration group in all the test items.

From the above results, it was revealed that wheat and potato shochu distilled lees do not show an acute adverse effect or lethal toxicity on normal rats. It has been shown that it does not show toxicity to specific organs. Biochemical tests revealed no abnormalities. Therefore, it was suggested that the distilled spirits of the shochu of the present invention can be used safely both as a pharmaceutical composition and as a health food.

[Brief description of the drawings]

FIG. 1 is a diagram showing a process for producing shochu.

FIG. 2 shows an infrared absorption spectrum of a freeze-dried substance of a supernatant liquid of potato shochu distilled lees.

FIG. 3 shows an ultraviolet absorption spectrum of a supernatant of a potato shochu distilled lees.

FIG. 4 is a graph showing the growth inhibitory effect of potato shochu distilled lees on various tumor cells.

FIG. 5 shows an infrared absorption spectrum of a freeze-dried substance of a supernatant liquid of wheat shochu distilled lees.

FIG. 6 shows an ultraviolet absorption spectrum of a supernatant liquid of distilled spirits from barley shochu.

FIG. 7 is a graph showing the effect of barley shochu distilled lees on the growth of various tumor cells.

FIG. 8 shows an infrared absorption spectrum of a freeze-dried substance of a supernatant liquid of rice shochu distilled lees.

FIG. 9 shows an ultraviolet absorption spectrum of a supernatant of rice shochu distilled lees.

FIG. 10 is a graph showing the inhibitory effect of rice shochu distilled lees on the growth of various tumor cells.

FIG. 11 is a graph showing changes in body weight of rats.

FIG. 12 is a diagram showing the weight of each organ of a rat after oral administration.

FIG. 13 is a diagram showing the weight of each organ of a rat after intravenous administration.

FIG. 14 is a diagram showing the results of blood biochemical tests on orally administered rats.

FIG. 15 is a diagram showing the results of a blood biochemical test of an orally administered rat.

FIG. 16 is a diagram showing the results of blood biochemical tests on rats administered intravenously.

FIG. 17 is a view showing the results of blood biochemical tests of rats administered intravenously.

 ────────────────────────────────────────────────── ─── Continuing from the front page (72) Ryuichi Kamioka, Inventor 3-9-1, Izumi, Kumamoto City, Kumamoto Prefecture (72) Inventor Shigeru Hirose 1-13-25 Shinsei, Kumamoto-shi, Kumamoto F-term (reference) 4B018 LE03 LE05 MD91 ME08 MF01 MF06 4C088 AB12 BA09 CA05 MA16 MA44 NA14 ZB26

Claims (7)

[Claims] 1. A pharmaceutical composition for preventing or treating tumors, comprising shochu distilled lees as an active ingredient. 2. The pharmaceutical composition according to claim 1, wherein the distilled shochu lees is a centrifuged supernatant thereof. 3. The pharmaceutical composition according to claim 1, wherein the distilled shochu lees is a lyophilized supernatant of the centrifuged supernatant. 4. The pharmaceutical composition according to claim 1, wherein the tumor is gastric cancer. 5. A health food comprising shochu distilled lees. 6. The health food according to claim 5, wherein the distilled spirits of shochu is a supernatant obtained by centrifugation. 7. The health food according to claim 5, wherein the distilled spirits of shochu is a freeze-dried supernatant of the centrifuged supernatant.