Tumor suppressants

Abstract

The present invention provides a tumor suppressant comprising a composition that enables the tumor suppression effect to be fully exerted while suppressing side effects. [Solution] The tumor suppressant composition contains cholera toxins and lactic acid bacteria culture as active ingredients, and the lactic acid bacteria culture may further contain cultures of three species: Lactobacillus fermentum, Lactobacillus subtilis, and Actinomycete SIID11972.

Description

[Technical Field]

[0001] This invention relates to a tumor suppressant containing mixed bacteria. [Background technology]

[0002] In recent years, some antitumor agents with antiviral effects have strong side effects, and their use is restricted. Therefore, developing antitumor agents with fewer side effects is a major challenge. One reason why developing antitumor agents with fewer side effects is difficult is that pharmacological effects and side effects are closely related, and suppressing side effects leads to suppression of pharmacological effects. Known side effect suppressants that act on antitumor agents include amifostine for cisplatin, potassium oxonate for 5-fluorouracil, and combinations of cisplatin, cyclophosphamide, or doxorubicin hydrochloride with chromanol glycosides. While such antitumor agents are effective in suppressing tumors, due to the characteristics of tumor cells, resistant strains to the originally used drugs exist, and such resistant strains easily acquire tolerance to antitumor agents. Therefore, in order to exert an effective tumor-suppressing effect, the selection and combination of multiple antitumor agents is usually necessary, and this is not definitive for effective treatment with fewer side effects (see, for example, Patent Documents 1 and 2).

[0003] Furthermore, known immunostimulatory compositions include, for example, a mixed culture of Saccharomyces cerevisiae and 3-8 types of lactic acid bacteria selected from the group consisting of Lactobacillus delbuccae, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus fermentum, Lactobacillus casei, Lactobacillus rhamnosus, Lactococcus lactis, and Streptococcus thermophilus, or a mixed bacterial culture or culture supernatant derived from said mixed culture (see, for example, Patent Document 3).

[0004] Furthermore, tumor suppressants are also known that use lactic acid bacteria belonging to the Lactobacillus genus, lactic acid bacteria belonging to the Bifidobacterium genus, and lactic acid bacteria belonging to three genera of Streptococcus, and form multiple groups using one or more lactic acid bacteria selected from these three genera, maintain a symbiotic state by subculturing each group, and further co-culturing these subculturified group units to obtain a lactic acid bacteria culture solution, which is then heat-sterilized and filtered, and the filtrate obtained by mixing this with a powder made from the residue obtained when filtering the filtrate. (See, for example, Patent Document 4). However, as mentioned above, these drugs may not be definitive for treatment aimed at suppressing tumors or side effects. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] Patent No. 2614164 [Patent Document 2] Patent No. 4509574 [Patent Document 3] Japanese Patent Publication No. 2005-068092 [Patent Document 4] Japanese Patent Publication No. 2005-097280 [Overview of the Initiative] [Problems that the invention aims to solve]

[0006] The technology disclosed herein was made in view of the above circumstances, and its purpose is to provide a tumor suppressant comprising a composition that can fully exert a tumor-suppressing effect while suppressing side effects. [Means for solving the problem]

[0007] To address the above-mentioned problems, this disclosure includes a tumor suppressant characterized by containing cholera toxins and a lactic acid bacteria culture as active ingredients. The lactic acid bacteria culture contains Lactobacillus fermentum, Lactobacillus subtilis, and Actinomycete SIID11972. It would be acceptable to do so.

[0008] Cholera toxins, when ingested, exert pharmacological effects on various diseases, including muscular dystrophy and diabetes, and also exert tumor-suppressing effects. However, they also have strong side effects; specifically, symptoms such as cytotoxicity, organ damage, and weakened immune function may occur after ingestion of cholera toxins. In contrast, lactic acid bacteria cultures are a composition found in food and have the effect of suppressing the side effects of cholera toxins. That is, tumor suppressants containing cholera toxins and lactic acid bacteria cultures as active ingredients can achieve both tumor suppression and suppression of the side effects that may result from it. In particular, the effect of suppressing side effects is remarkable when the lactic acid bacteria culture contains cultures of three types of bacteria: Lactobacillus fermentum, Lactobacillus subtilis, and Actinomycete SIID11972. Furthermore, when the lactic acid bacteria culture contains Lactobacillus fermentum as the main component among the three cultures, the effect of suppressing side effects is even more significantly exhibited.

[0009] Furthermore, in this disclosure, the lactic acid bacteria culture may consist of Lactobacillus fermentum, skim milk powder, natural salt, molasses, monosodium glutamate, potato starch, and defatted soybean flour. Specifically, it may consist of 1.5% Lactobacillus fermentum culture solution, 4% skim milk powder, 1.5% natural salt, 1% molasses, 0.5% monosodium glutamate, 6% potato starch, 7% defatted soybean flour, and 100% (by weight) purified water. After culturing this at 40°C for 48 hours, it is mixed into a slurry using a mixer, and then cultured at an inlet temperature of 150°C and an outlet temperature of 75°C. By using a spray dryer, it is possible to obtain a dried powder of lactic acid bacteria culture. By mixing this dried powder of lactic acid bacteria culture with cholera toxins, it is possible to achieve both tumor suppression and suppression of the side effects that may result therefrom, as described above. Furthermore, the dried powder of lactic acid bacteria culture can be easily manufactured by the method described above.

[0010] Furthermore, in this disclosure, Lactobacillus fermentum is defined as NBRC 3071, and It may also be a metabolic derivative of NBRC 3071. NBRC 3071 is a known microorganism, and its dried product is readily available. Furthermore, the metabolic derivative of NBRC 3071 may be used, for example, in extreme environments. It can be easily obtained by methods such as conditioning, UV irradiation, chemical treatment, or genetic modification.

[0011] Furthermore, in this disclosure, the drug may be formulated as tablets, granules, or capsules by mixing it with at least one of dextrin, starch, acacia gum, lactose, sucrose, crystalline cellulose, carboxymethylcellulose, methylcellulose, stearate, talc, or anhydrous silicic acid. This makes it possible to ingest the tumor suppressant orally. For example, in the case of parenteral administration such as injection, the tumor suppression effect may only be obtained locally, but in the case of oral administration, the tumor suppression effect can be evenly distributed throughout the body. In addition, oral administration can be done by one person at home, for example, and does not require special medical equipment such as syringes, making it relatively easy and inexpensive to perform.

[0012] Furthermore, the means for solving the above problems can be used in combination with each other as much as possible. [Effects of the Invention]

[0013] According to the technology disclosed in this application, it is possible to sufficiently exert the effect of suppressing tumors while suppressing side effects.

Mode for Carrying Out the Invention

[0014] 〔Embodiment 1〕 Hereinafter, a tumor inhibitor according to Embodiment 1 of the present disclosure will be described. Note that the tumor inhibitor according to Embodiment 1 of the present disclosure is not intended to be limited to the following configuration.

[0015] The tumor inhibitor according to Embodiment 1 contains cholera toxins and a lactic acid bacteria culture as active ingredients. The lactic acid bacteria culture contains three cultures of Lactobacillus fermentum, Lactobacillus subtilis, and Actinomyces SIID11972 as active ingredients. Cholera toxins is a proteinaceous compound composed of a heterohexamer with a molecular weight of about 84,000, consisting of 1 subunit with a molecular weight of about 27,000 and 5 subunits with a molecular weight of about 11,600. Cholera toxins have pharmacological effects on various diseases including muscular dystrophy and diabetes, and also have the effect of suppressing tumors. These mechanisms of action depend on the accumulation of cAMP by ADP-ribosylation of Gs protein in tumor cells and the induction of differentiation of tumor cells by the binding of the above subunit with a molecular weight of about 11,600 to ganglioside GM1 on the surface of tumor cells. Cholera toxins can be produced, for example, using the product of Vibrio cholerae as a raw material, or by using techniques such as genetic recombination. On the other hand, the lactic acid bacteria culture containing three cultures of Lactobacillus fermentum, Lactobacillus subtilis, and Actinomyces SIID11972 as active ingredients can reduce the side effects caused by cholera toxins

[0016] ​It has the effect of suppressing. That is, by containing cholera toxins and lactic acid bacteria cultures as active ingredients, the tumor suppressor can sufficiently exert the effect of suppressing tumors while suppressing side effects. In addition, by containing the above three cultures as active ingredients in the lactic acid bacteria culture, it is possible to further improve the effect of suppressing side effects. Moreover, the lactic acid bacteria culture may be used for food and has high safety when ingested into the body.

[0017] Moreover, Lactobacillus fermentum is an anaerobic bacterium, and Lactobacillus subtilis and actinomycetes SIID11972 are aerobic bacteria. Therefore, the symbiosis of these three cultures makes it possible for Lactobacillus subtilis and actinomycetes SIID11972 to absorb the oxygen released by Lactobacillus fermentum. As a result, for the tumor suppressor, Lactobacillus subtilis and actinomycetes SIID11972 can maintain an active state without dormancy even in an oxygen-free environment such as the human intestine.

[0018] The culturing process of Lactobacillus fermentum will be described. First, a BCP plate count agar medium is formed by pouring melted agar into a petri dish (a circular glass container), and the Lactobacillus fermentum strain is spread into a layer with a thickness of 2 mm using a platinum rod. Then, the petri dish coated with the Lactobacillus fermentum strain is placed in an incubator and cultured at a constant temperature of 37°C for 24 hours, and then placed in a 20 L fermenter box. Next, 1 L of distilled water is put into a 2 L wide-mouth bottle, and 5 g of yeast, 5 g of glucose, and 5 g of peptone are mixed to produce. Then, the produced mixed solution is put into an autoclave and heated at a constant temperature of 120°C for 20 minutes for sterilization, and then cooled to below 40°C to produce a culture solution.

[0019] Next, this culture solution is put into a 20 L fermenter box, 100 g of a growth medium (such as soybean powder), starch 200g of potato starch, 100g of brown sugar syrup, 400g of trehalose, 200g of skim milk, and refined Add 10 mL of water to make a 1000 mL mixed solution. Next, immerse the Baron box containing this mixed solution in 37°C warm water for 48 hours, then remove the Baron box and degas it. Next, dry this mixed solution using a heat storage drying method, and then transfer it to a stainless steel tray.

[0020] Next, the mixed solution in the stainless steel tray is dried at 37°C for 48 to 52 hours, allowing the moisture to gradually evaporate until the moisture content is 8% or less. Finally, the dried mixture is mixed. Single and then distribute using a mesh.

[0021] Next, we will explain the culture process of Lactobacillus subtilis. Lactobacillus subtilis is a type of Bacillus subtilis (natto bacterium). First, commercially available natto is placed in a 2L wide-mouthed jar and immersed in 1000mL of purified water, and then mixed with 5g of peptone, 5g of extra yeast, and 5g of glucose. Then, the resulting mixture is placed in an autoclave and boiled at a constant temperature of 120°C for 20 minutes. After cooling, add another 5g of natto and place in an incubator, culturing at a constant temperature of 37°C for 24 hours. Then, filter the resulting culture solution through filter paper, and place 1000mL of the filtered culture solution into a 20L Baron box. Place the mixture in a container, add 1000g of Soyfit, 200g of skim milk, 200g of starch (such as potato starch), 400g of trehalose, and 200g of the culture solution before filtering, and culture for 48 hours. Then transfer to a stainless steel tray.

[0022] Next, the mixed solution in the stainless steel tray is dried at 37°C for 52 hours to gradually evaporate the water until the moisture content is 8% or less. This releases the ammonium compounds from the mixed solution. The monia odor is eliminated. Finally, the dried mixture is mixed and separated through a mesh.

[0023] Next, we will explain the culture process for the actinomycete SIID11972. First, use commercially available pineapple peels. The pineapple peel is removed, finely chopped, and dried in the sun. This sun-drying process allows the actinomycete SIID11972 to grow using the pineapple peel as a culture medium. Next, the sun-dried pineapple peel... The peels are ground in a blender, 50g of the ground peels are placed in a 2L wide-mouthed jar and immersed in 1000mL of purified water, and cultured. Prepare the nutrient solution. Next, place the actinomycete SIID11972 into an incubator at 37°C and allow it to grow for 24 hours. The inoculum of the actinomycete SIID11972 is grown and inoculated. The inoculated inoculum is then filtered using filter paper. Next, 10 liters of purified water are placed inside a 20-liter Baron box, and the filtered solution of actinomycetes SIID11972 is added to it.

[0024] Next, add 2 kg of the mixture to a 20 L Baron box. Specifically, 1000 g of soy flour. Add 200g of skim milk, 200g of starch (potato starch), 400g of trehalose, and 200g of a solution of actinomycete SIID11972, and then culture and grow for 48 hours. Next, this mixed solution is put into a stainless steel tray. Transfer to a separate container, add the dry material, and dry for 72 hours. Next, reduce the moisture content of the dried mixture to 8% or less. Allow to dry completely. Finally, mix the dried mixture and strain it through a mesh.

[0025] When preparing the three cultures, Lactobacillus fermentum, Lactobacillus subtilis, and Actinomycete SIID11972, powdered as described above, are mixed in a mass ratio of 2:1:1. This ensures that each bacterium has high purity, and the effect of Actinomycete SIID11972 maintaining its active state without dormancy even in an anaerobic environment such as the human intestine is more easily achieved. It will decrease.

[0026] Furthermore, Lactobacillus fermentum may be NBRC 3071, a type of microorganism, or a metabolic derivative of NBRC 3071. NBRC 3071 may be in liquid form, but may also be used as a dried product. It is particularly preferable to manufacture it using 1.5% pure culture solution of NBRC 3071, 4% skim milk, 0.5% to 1.5% natural salt, 1% molasses, 0.5% monosodium glutamate, 2% to 6% potato starch, and evaporatively processed ingredients. Mix 3% to 9% fatty soy flour with 100% purified water, and after a predetermined incubation period, use a spray dryer set to an inlet temperature of 150°C to 180°C and an outlet temperature of 75°C to 87°C. After spray drying, the number of viable bacteria was 1.1 × 10⁶. 9 cfu / g ~ 1.2 × 10 10 It is manufactured as a dry powder with a cfu / g concentration and an average particle size of 1 μm to 9 μm. Furthermore, metabolic derivatives of NBRC 3071 can be easily obtained by methods such as conditioning in extreme environments, UV irradiation, chemical treatment, or genetic modification. It is possible to do so.

[0027] Furthermore, tumor suppressants can be formulated as separate preparations for cholera toxins and Lactobacillus fermentum cultures, or as a single preparation. Hereafter, a lactic acid bacteria culture containing Lactobacillus fermentum as the main component will simply be referred to as Lactobacillus fermentum. When formulated as separate preparations, the timing of administration of Lactobacillus fermentum culture in relation to cholera toxin administration can be arbitrarily set. That is, the timing of administration of Lactobacillus fermentum culture or its derivatives can be before or after the administration of cholera toxins, or simultaneously with the administration of cholera toxins, but it is preferable to administer it one hour before or simultaneously with the administration of cholera toxins.

[0028] When administering tumor suppressants, cholera toxins should be administered in a range of 0.005-200 mg / kg, preferably 5-100 mg / kg. Lactobacillus fermentum culture should be administered in a range of 10-2,000 mg / kg, preferably 100-1,000 mg / kg. (Tumor suppression) The drug is compounded with a carrier acceptable for formulation and prepared into various formulation forms. For example, it can be mixed with various excipients such as dextrin, starch, gum arabic, lactose, sucrose, and crystalline cellulose, disintegrants such as carboxymethylcellulose and methylcellulose, and lubricants such as stearate, talc, and anhydrous silicic acid, and formulated into tablets, granules, or capsules. Tumor suppressants in such dosage forms can be taken orally, which prevents localized tumor suppression compared to parenteral administration such as injection. Oral administration is also relatively easy and inexpensive to perform.

[0029] [Embodiment 2] Furthermore, the tumor suppressant according to Embodiment 2 of this disclosure may be composed of a different composition from the composition constituting the tumor suppressant according to Embodiment 1. For example, the lactic acid bacteria culture according to Embodiment 2 may consist of 1.5% Lactobacillus fermentum (hereinafter abbreviated as Lb-f) culture solution, 4% skim milk powder, 1.5% natural salt, 1% molasses, 0.5% sodium glutamate, 6% potato starch, 7% defatted soybean flour, and 100% (by weight) purified water. In Embodiment 2, this is cultured at 40°C for 48 hours, then mixed into a slurry, and then the inlet temperature is 150°C. A dried powder of the Lb-f culture was produced using a spray dryer under conditions of an outlet temperature of 75°C. The powder thus obtained, along with cholera toxin powder (hereinafter, cefotaxime sodium (CTX) is used as an example), was sieved and then mixed in a ratio of 1:1.8-28.8 (by weight) to obtain the test powder (CTX + Lb-f agent).

[0030] The tumor suppressant according to Embodiment 2 may have similarities with the tumor suppressant according to Embodiment 1, except for the points mentioned above. For example, Lb-f constituting the lactic acid bacteria culture according to Embodiment 2 may be NBRC 3071 or a metabolite of NBRC 3071, and the tumor suppressant according to Embodiment 2 may be formulated as tablets, granules, or capsules.

[0031] In subsequent Examples 1-4, the above-mentioned Lb-f dried powder, CTX powder, and test powder were used. The results of a tumor growth suppression test using the agent are given as an example.

[0032] [Example 1] <Tumor growth suppression test> Next, the Lb-f dried powder and CTX powder described in Embodiment 2 above were carried out in Example 1. The following describes a tumor growth inhibition test using the test powder. In Example 1, the Lb-f dried powder, CTX powder, and test powder were suspended in physiological saline at the time of administration. The solution was administered orally using a catheter after adjusting the volume to 0.1 mL per 10 g of mouse body weight. Animal experiments were conducted in accordance with the experimental animal handling regulations of the China National Institute of Pharmaceuticals and Biological Products, with continuous feeding and SPF rearing. Human colon cancer (HT-29) cells were transplanted subcutaneously into the backs of Balb / c nude mice (female, 4 weeks old, 65 females, 4-5 weeks old, body weight 7-11 g) (2 × 10 6 cells / animal), volume of transplanted tumor 100mm 3 After reaching the above stage (14 days post-transplant), the animals were divided into 13 groups of 5 based on average body weight and tumor volume. Each group and dosage are shown in Table 1 below. Administration was performed every two days for a total of 9 days. The procedure was carried out in several stages. The volume of the transplanted tumor was measured on day 0 and day 20 after the start of the administration trial. The relative tumor volume was calculated. The relative tumor volume was calculated from the ratio of tumor volumes on day 0 and day 20 after the start of the administration study (tumor volume on day 20 / tumor volume on day 0). The transplanted tumor was measured every 5 days using calipers to measure its longest and shortest diameters, and the standard formula (V = L × w) was used. 2 The tumor volume was measured using ×0.5². V, L, and W represent tumor volume, longest diameter, and shortest diameter, respectively. Transplanted tumor weight was measured 20 days after the start of the study, after the transplanted tumor volume was measured, the tumor was removed, and its weight was measured. The tumor suppression rate was calculated as (l - each treatment group) The calculation was performed using the formula: (average tumor weight / average tumor weight of the control group) × 100%.

[0033] [Table 1] As shown in Table 1, administering Lb-f and CTX in combination is effective compared to administering Lb-f alone. Compared to the case where only one drug was administered, a significant tumor suppression effect was observed. In particular, in combination group 4 (CTX 50 mg / kg + Lb-f 180 mg / kg), the tumor suppression rate improved by 188% and 129%, respectively, compared to when Lb-f and CTX were administered individually. Based on these results, it can be concluded that tumor suppression is effective when administered to human colon cancer cells. In tumors, the combined administration of Lb-f and CTX exhibits excellent tumor-suppressing effects and improves tumor control. It has been demonstrated that it is possible to reduce the required dose of CTX. See Table 1. The value p represents the probability that the null hypothesis is true and the observed value is actually observed.

[0034] [Example 2] <Side effect suppression test> Next, we will describe the adverse effect suppression test by oral administration of Lb-f conducted in Example 2. In Example 2, Balb / c nude mice (40 females, 4 weeks old, body weight 8-10 g) were used, and Tumor graft volume is 100 mm 3 After reaching the above (14 days after transplantation), the body weight and tumor volume are averaged and 1 The mice were divided into eight groups of five. The individual groups and dosages are shown in Tables 2 and 3 below. Similar to Example 1, oral administration was performed a total of nine times at intervals of two days. The body weight of each mouse was measured by the dosage. Measurements were taken on day 0 and day 20 after the start of the study. Subsequently, blood samples were taken from the posterior orbital venous plexus for blood testing. Blood samples were taken (1.0 mL per individual). The white blood cell count in the blood was measured using a hemocytometer, and serum samples were also taken. The analysis was performed according to standard procedures. Serum levels of LDH (lactate dehydrogenase), ALT (alanine aminotransferase), AST (aspartate aminotransferase), Cr (chromium), and BUN (blood urea nitrogen) were measured using an automated biochemical analyzer (Hitachi, Ltd.) and a Begiman CX7 biochemical analyzer (Begiman strain). Measurements were taken using (a specific measurement method). Elevated LDH and Cr levels are indicators of organ inflammation, while elevated BUN levels are an indicator of decreased kidney function. The percentage change in body weight was calculated using the formula: [body weight gain in the test group (g) / body weight gain in the control group (g) × 100%]. Other test methods and statistical processing of measured values ​​were the same as in Example 1.

[0035] [Table 2] [Table 3] As shown in Table 2, the control group (CTX monotherapy group) showed a significant change in body weight compared to the other groups. The rate showed a decrease. On the other hand, in each combination therapy group (CTX + Lb-f administration group), the decrease in the rate of weight change observed in the control group was significantly improved. This improvement effect tends to depend on the Lb-f dosage. In addition, each Lb-f monotherapy group maintained a rate of weight change comparable to the control group. Furthermore, as shown in Tables 2 and 3, when measuring various blood parameters indicating cell and organ damage or functional impairment, the combination therapy of CTX and Lb-f and Lb-f monotherapy showed similar effects compared to the control group and the control group (CTX monotherapy group). Based on these results, the combination therapy of CTX and Lb-f Administration is necessary to significantly reduce the side effects of CTX monotherapy, such as cytotoxicity, organ damage, and decreased immune function. It is clear that it has a mitigating effect. Furthermore, oral administration of Lb-f alone has been shown to be highly safe for the body.

[0036] [Example 3] <Tumor growth suppression test> Next, we will describe the tumor growth suppression test performed in Example 3. In Example 3, human gastric cancer cells (SGC-7901) were introduced into Balb / c nude mice (52 females, 4-5 weeks old, body weight 7-11 g). Transplanted subcutaneously into the back (3 x 10 6 cells / animal), transplanted tumor volume 100 mm 3 After reaching the above stage (14 days post-transplant), the animals were divided into 13 groups of 4 animals each, based on average body weight and tumor volume. The individual groups and dosages are shown in Table 4 below. Other test methods and statistical processing of measured values ​​were the same as in Example 3.

[0037] [Table 4] As shown in Table 4, even in tumors derived from human gastric cancer cells, the combination of CTX and Lb-f showed a better tumor-suppressing effect compared to CTX or Lb-f monotherapy, similar to the studies in tumors derived from colon cancer cells. These results suggest that the combination of CTX and Lb-f exhibits a superior tumor-suppressing effect even in tumors derived from human gastric cancer cells, and that it is necessary for tumor suppression. It is clear that it is possible to reduce the dosage of CTX.

[0038] [Example 4] <Side effect suppression test> Next, we will describe the side effect suppression test conducted in Example 4. In Example 4, Balb / c nude mice (32 females, 4 weeks old, body weight 8-10 g) were given human gastric cancer cells (SGC-7901) in the back. The cells were transplanted subcutaneously (3 × 10⁶ cells / animal), and the transplanted tumor volume was 100 mm².3 After reaching the above (14 days after transplantation), the body weight and tumor volume were averaged and divided into 8 groups of 4 mice per group. Each test group and dosage are shown in Tables 5 and 6 below. Similar to Example 1, oral administration was performed a total of 9 times at intervals of once every 2 days . The body weight of each mouse was measured on the 0th and 20th days after the start of the administration test. Then , blood was collected from the retro-orbital venous plexus for blood tests (1.0 mL per individual). Serum preparation, measurement of blood LDH, Cr, BUN, other test methods, and statistical processing of the measured values were the same as in Example 1

[0039]

Table 5

Table 6

[0040] As is also clear from the tests shown in Examples 1 - 4 above, the tumor suppressor containing CTX and Lb-f as active ingredients shows an excellent tumor suppression effect while being able to suppress side effects such as cytotoxicity. That is, CTX binds to a compound that can react with a specific substance in tumor cells ​It has high potential as a targeted tumor suppressant when combined with other substances. Furthermore, it exhibits pharmacological effects on various diseases, including muscular dystrophy and diabetes, while being usable in the treatment of these conditions without concerns about toxicity. Moreover, because it is highly safe when ingested, tumor suppressants can be taken orally and exert their pharmacological effects fully within the body.

Claims

1. The active ingredients are cholera toxins and lactic acid bacteria culture. The lactic acid bacteria culture is characterized by containing Lactobacillus fermentum, Lactobacillus subtilis, and a predetermined actinomycete in a mass ratio of 2:1:1, and is a tumor suppressant.

2. The tumor suppressant according to claim 1, which can be formulated as tablets, granules, or capsules by mixing with at least one of dextrin, starch, gum arabic, lactose, sucrose, crystalline cellulose, carboxymethylcellulose, methylcellulose, stearate, talc, or anhydrous silicic acid.

3. A method for producing a tumor suppressant according to Claim 1, characterized in that Lactobacillus fermentum, Lactobacillus subtilis, and a predetermined actinomycete are each cultured for 48 hours, dried to a moisture content of 8% or less, powdered, and mixed in a mass ratio of 2:1:1.