JP2010111646A - Treating agent for ulcerative colitis - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a treating agent for ulcerative colitis having excellent therapeutic effect. <P>SOLUTION: The treating agent for ulcerative colitis contains 10-hydroxy-2-decenoic acid as an active component. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to an excellent therapeutic agent for ulcerative colitis having 10-hydroxy-2-decenoic acid as an active ingredient and having few side effects.

  Ulcerative colitis is a nonspecific inflammatory bowel disease that forms erosions and ulcers in the mucosal layer or submucosa of the large intestine mucosa, and its clinical symptoms include characteristic findings such as diarrhea, bloody stool, abdominal pain and weight loss It is done. Although it has been a relatively rare disease in Japan, the number of patients has been rapidly increasing year by year with the Westernization of dietary habits. Although various factors such as enteric bacterial infection, food allergies, vascular disorders, autonomic disorders and immune abnormalities are considered as the cause, details are still unknown, and no fundamental treatment has been established. Is the current situation. At present, as pharmacotherapy, steroid hormones, sulfa drugs such as salazosulfapyridine, and immunosuppressants such as azathioprine and mercaptopurine are administered alone or in combination. In addition, as for the ingredients that are widely used as food materials, Patent Document 1 discloses trehalose, Patent Document 2 catechins, Patent Document 3 lysine, Patent Document 4 Isoflavones and the like have been proposed.

  However, ulcerative colitis treatment agents generally need to be used continuously for a long period of time, so if you do not want to use them with a single component alone, or if you do not have sufficient effects Therefore, development of a novel ulcerative colitis therapeutic agent is desired.

Japanese Patent Laid-Open No. 10-17478 Japanese Patent Laid-Open No. 11-116475 International Publication WO2006 / 46746 Pamphlet JP 2007-63138 A

  It is an object of the present invention to provide a therapeutic agent for ulcerative colitis having an excellent therapeutic effect.

  As a result of searching for various substances in view of the above problems, the present inventors have unexpectedly found that 10-hydroxy-2-decenoic acid (hereinafter referred to as “decenoic acid” in this specification) has ulcerative colitis. The present invention has been completed by finding that there is a preventive or therapeutic effect on the disease. That is, the present invention relates to a therapeutic agent for ulcerative colitis containing decenoic acid as an active ingredient.

  The therapeutic agent for ulcerative colitis of the present invention, when taken orally, suppresses the formation of erosion and ulcers of the colonic mucosa, and prevents or improves symptoms such as diarrhea, bloody stool, abdominal pain and weight loss. Excellent therapeutic effect for ulcerative colitis.

  The treatment of ulcerative colitis as used in the present invention refers to prevention and improvement of erosion and exacerbation of erosions and ulcers of the mucosa or submucosa of the large intestine in ulcerative colitis, and its clinical symptoms are diarrhea, It means prevention and improvement of bloody stool, abdominal pain and weight loss. It also includes prolonging the remission phase of ulcerative colitis, relapse, and prevention of recurrence.

  The decenoic acid used in the present invention is not limited in its origin or production method, and may be a synthetic product or a natural product, and may be derived from a component derived from a raw material used in synthesis or a synthesis process. In addition, a partially purified product obtained by fractionation or the like, or a highly purified product may be used. As natural products, royal jelly, which has abundant dietary experience and is excellent in nourishing effect and safety, is preferable because it contains abundant decenoic acid. Specific examples of the royal jelly include raw royal jelly, dried royal jelly, prepared royal jelly, and extracts of these royal jelly with inorganic and / or organic solvents. The royal jelly extract is further subjected to chromatography, It may be a royal jelly fraction containing decenoic acid that is fractionated by using a membrane such as an ultrafiltration membrane. Of these, a royal jelly extract or a fraction thereof is desirable for ease of storage and handling. In addition, the royal jelly-derived protein has no therapeutic effect on ulcerative colitis, so the amount of protein component with allergenicity is reduced from the point of strength of therapeutic effect and low allergenicity Desirable royal jelly fraction. As the royal jelly fraction, for example, as shown in Example 4 below, the same applicant disclosed in the international patent application PCT / P2008 / 60126, the molecular weight cut off is about 30,000 to 6,000. The fraction obtained by removing the polymer fraction containing the protein contained in the royal jelly by a method such as ultrafiltration membrane or gel column chromatography, preferably a fraction having a molecular weight of 30,000 daltons or more, more preferably a molecular weight It is desirable to use a product having a reduced allergenicity obtained by removing a fraction having a molecular weight of 10,000 daltons or more, particularly preferably a fraction having a molecular weight of 6,000 daltons or more.

  The therapeutic agent for ulcerative colitis of the present invention comprises a composition containing decenoic acid such as decenoic acid or royal jelly as an active ingredient, and is usually used in the form of an oral intake. The dosage form in that case is not particularly limited, and may be used in the form of solid, powder, tablet, pill, granule, powder, capsule, liquid, syrup, paste, emulsion, etc. It is optional to ingest the mixture. In addition, when used by a parenteral route of administration, it may be used in the form of a suppository, solution, suspension, emulsion or the like.

  The therapeutic agent for ulcerative colitis of the present invention may use decenoic acid alone as a preparation as it is, but if necessary, an oral preparation or a high calorie combination with a pharmaceutically acceptable additive It may be an infusion preparation or the like, or a parenteral preparation used by adding to an infusion preparation. Specifically, for example, surfactant, preservative (antibacterial agent), moisturizer, thickener, water-soluble polymer, antioxidant, chelating agent, dye, fragrance, pH adjuster, excipient, disintegration What is necessary is just to formulate by a well-known method in combination with an agent, a coating agent, a binder, a lubricant agent, vitamins, various amino acids, electrolyte, an animal, a plant extract, etc. More specifically, in the production of oral preparations, for example, commonly used lactose, sucrose, maltose, trehalose, carbohydrate derivatives of trehalose, reducing or non-reducing carbohydrates such as cyclic tetrasaccharides, erythritol, sorbitol, etc. , Sugar alcohols such as maltitol, dextrin, starch, crystalline cellulose, corn starch, carboxymethylcellulose, agar, gelatin powder, polyvinyl alcohol, methylcellulose, hydroxypropylcellulose, silica, magnesium stearate, talc, hydroxypropylmethylcellulose, etc. Good. In the production of oral solutions such as solutions, suspensions, syrups, and injections, decenoic acid or a composition containing the same is dissolved or suspended in distilled water for injection, physiological saline, etc. For example, pH adjusting agents such as inorganic or organic acids or bases, isotonic agents, stabilizers, diluents and the like may be added as necessary.

  The therapeutic agent for ulcerative colitis of the present invention further contains, in addition to decenoic acid as an active ingredient or a composition containing the same, other ulcerative colitis such as other ulcerative colitis therapeutic agents and anti-inflammatory agents, if necessary. It is optional to add medicinal ingredients having an effect of improving the clinical symptoms of inflammation or to use in combination with a preparation containing these medicinal ingredients.

  The dose of the therapeutic agent for ulcerative colitis of the present invention varies depending on the administration method, patient age, body weight, symptoms, etc., but usually, in the case of oral administration to an adult, decenoic acid is converted into solid matter, The dose may be appropriately adjusted within the range of 0.02 to 20 mg / kg body weight, preferably 0.05 to 10 mg / kg body weight, particularly preferably 0.5 to 5 mg / kg body weight per day. Ingestion of less than 0.02 mg / kg / body weight per day may not provide the desired effect, and ingestion exceeding 20 mg / kg / body weight may not provide an effect commensurate with the intake. is there.

  The mixing ratio of decenoic acid to the therapeutic agent for ulcerative colitis of the present invention is not particularly limited as long as the therapeutic effect for ulcerative colitis is obtained, and can be adjusted so that the necessary amount per day can be ingested. Good. Specifically, the blending amount of decenoic acid is usually 0.01 to 100 mass (w / w)% in the case of a solid preparation, and 0.001 to 10 in the case of a liquid preparation. What is necessary is just to select suitably in the range of mass (w) / volume (v)%, respectively. In addition, when preparing a preparation using a composition containing decenoic acid such as a royal jelly extract, the amount of decenoic acid in the preparation is calculated based on the amount of decenoic acid in the composition, and the blending amount is calculated. Just decide.

  Since the therapeutic agent for ulcerative colitis of the present invention has the action of generating ulcerative colitis and prolonging the remission period, it can be used as a prophylactic agent for ulcerative colitis or an agent for prolonging the remission period. It can be carried out advantageously.

Hereinafter, the present invention will be described more specifically by experiments.
<Experiment 1>
<Effect of decenoic acid on ulcerative colitis>
<Test sample>
Decenoic acid was used as a test sample, and the effect on ulcerative colitis model rats was examined. That is, 15 mg of commercially available reagent-grade decenoic acid (sold by Alfresa Pharma, purity 99 mass (w / w)% or more) is weighed, dissolved in 75 mL of distilled water (200 μg / mL), subdivided, and stored refrigerated It was used.

<Test animal>
As test animals, 13 SD male rats (4 weeks old, sold by Charles River Japan, Inc.) were used after preliminary breeding for 1 week. That is, the rats were preliminarily raised in an automatic water supply rack with a wire mesh placed in a polycarbonate cage. During the preliminary breeding, a commercially available powdered feed for rats having the composition shown in Table 1 (product number “CE-2”, sold by CLEA Japan, hereinafter abbreviated as “CE diet”) is given using a feeder. It was. After preliminary breeding, the weight of each rat was measured, and 3 animals were assigned to test group 1, 6 animals were assigned to test group 2, and 4 animals were assigned to test group 3 so that the average weights of each test group were equalized. , Each transferred to a metabolic cage.

<Induction of ulcerative colitis>
Rat ulcerative colitis, which is used as a model for developing human ulcerative colitis, is orally ingested with sodium dextran sulfate (hereinafter abbreviated as “DSS”) according to the method of Kanauchi et al. (See “J. Gastroenterol. Hepatol.”, Vol. 16, pages 160 to 168 (2001)). That is, a part of the corn starch in the CE food having the composition shown in Table 1 is replaced with DSS (average molecular weight 5,000, sold by Wako Pure Chemical Industries, Ltd.), and the blending amount is 5 mass (w / w)%. A feed prepared so as to be (hereinafter referred to as “DSS diet”; see Table 1 for the composition) was induced for 8 days to induce ulcerative colitis. Hereinafter, the number of days after the start of DSS meal intake is expressed as 0 days as the DSS meal intake start date.

<Effect of decenoic acid on symptoms of ulcerative colitis>
Three groups of rats transferred to the above-mentioned pre-bred metabolic cage were ingested with a sample and food according to the schedule shown in Table 2, and the effect of decenoic acid on ulcerative colitis was examined. That is, 3 groups of rats were orally administered with distilled water (test group 1 and test group 2) or test sample (test group 3) once a day, as a sample, at 5 mL / animal / day using a sonde. While ingesting, the mice were bred for 1 week on a CE diet (breeding period 1). From the day after the end of this breeding period 1, rats in test group 1 were raised for 8 days on a CE diet while orally ingesting distilled water once a day, 5 mL / animal / day using a sonde. (Raising period 2). Rats in test group 2 were reared for 8 days on a DSS diet while taking distilled water orally once daily at 5 mL / animal / day using a sonde (breeding period 2). Test group 3 rats were reared for 8 days on a DSS diet while orally ingesting the test sample once a day, 5 mL / animal / day using a sonde (breeding period 2). For each rat, fecal observation was performed with the naked eye during the period 2 (8 days) and the next day (DSS food intake 8 days), and the symptom score of ulcerative colitis was calculated by the following evaluation method. The results are shown in Table 3. In addition, the number of surviving rats in each group on the day after the end of the rearing period 2 (DSS ingestion 8 days) was confirmed, and each surviving rat was dissected under anesthesia, blood was collected from the abdominal vena cava, and the hematocrit was collected. The value (%) was measured by a conventional method (microhematocrit method) to obtain an average value. The results are also shown in Table 3.

<Evaluation method of ulcerative colitis>
Symptoms of ulcerative colitis induced by DSS diet intake were evaluated by a symptom score (Disease Activity Index: DAI). That is, according to the method of Tsubouchi et al. (“Digestion”, Vol. 74, pp. 91 to 100 (2006)), scoring was performed based on the properties and color of stool. Symptoms of diarrhea were determined according to the characteristics of feces and scored according to four levels: normal (0), slightly soft stool (1), soft stool (2), and watery stool (3). Blood stool was scored according to the color tone of stool, which was determined in four stages: normal (0), brown (1), reddish brown color (2), and blood stool (3). The total of the diarrhea score and blood stool score was defined as DAI (maximum 6). In statistical processing, a significant difference test was performed on the DAI of the DSS intake group and the test sample intake group by the Mann-Whitney U test, and p <0.05 was considered significant.

  As is clear from Table 3, the DAI of the rats in Test Group 1 that received the CE diet and distilled water was 0, and there was no abnormality in stool (Table 3 shows whether there was a significant difference) Not displayed). In contrast, during the CE food intake period (breeding period 1) and during the period when the DSS meal was consumed for 8 days (bred period 2), distilled water was ingested once a day, daily. Rat DAI increased from the day after the start of DSS diet intake (DSS ingestion day 1) and became 6.0 on the day after ingesting the DSS diet for 8 days (DSS ingestion day 8), with watery bloody stool Stool was confirmed and ulcerative colitis was induced. Two out of six died due to worsening symptoms. During the CE food intake period (breeding period 1) and during the period when the DSS meal was ingested for 8 days (bred period 2), the test sample (decenoic acid 1 mg / kg · body weight / day) was once a day, daily. The DAI of the rats in the test group 3 ingested was significantly lower than that in the test group 2. None of the rats died. In addition, when the hematocrit values of the three groups of rats were compared, test group 2 showed a low value of 25.5%, whereas in test group 3 ingested decenoic acid, the decrease was significantly suppressed. , Almost the same value as in test group 1 that did not develop ulcerative colitis, and decenoic acid was also significant for a decrease in hematocrit, which is an indicator of anemia, which is a characteristic symptom of ulcerative colitis It was confirmed that there was an improvement effect. This result indicates that decenoic acid has an effect of suppressing the progression of ulcerative colitis and can be used for the prevention, improvement and treatment of human ulcerative colitis.

<Experiment 2>
<Effects of royal jelly ingredients on ulcerative colitis>
In Experiment 1, since decenoic acid was confirmed to have a therapeutic effect on ulcerative colitis, a test was conducted to confirm that royal jelly, which is known to contain abundant decenoic acid, has the same effect. That is, four types of royal jelly components containing the amounts of decenoic acid shown in Table 4 were used as test samples. 30 SD male rats (4 weeks old, sold by Charles River Japan Co., Ltd.) were preliminarily raised in the same manner and schedule as in Experiment 1, and the test group (group 5) shown in Table 5 has an average weight of each group. To equalize, each 6 animals were assigned and transferred to a metabolic gauge. Among these rats, group 4 has the same schedule as that of test group 3 shown in Table 2, and samples (any of the test samples) were used once a day, daily, 5 mL / animal / day, using a sonde. Ingested orally and fed for 1 week on CE diet (breeding period 1), then raised on DSS diet for 8 days (bred period 2) to induce ulcerative colitis (each royal jelly component ingested as a test sample) Based on the above, they are referred to as “raw royal jelly intake group”, “royal jelly fraction A intake group”, “royal jelly fraction B intake group”, and “royal jelly protein intake group”). As a control, the remaining one group was orally ingested with 5 ml / animal / day, a sample once a day, daily (distilled water) on the same schedule as that of test group 2 shown in Table 2. However, after being bred for 1 week on the CE diet (breeding period 1), it was raised on the DSS diet for 8 days (bred period 2) to induce ulcerative colitis (distilled water group). For each rat, fecal observation was performed with the naked eye during the period 2 (8 days) and the next day (DSS diet intake 8 days), and the symptom score of ulcerative colitis was calculated using the same evaluation method as in Experiment 1. . The results are shown in Table 5. In addition, the number of surviving rats in each group on the day after the end of the rearing period 2 (DSS ingestion 8 days) was confirmed, and each surviving rat was dissected under anesthesia, blood was collected from the abdominal vena cava, and the hematocrit was collected. The value (%) was measured by a conventional method (microhematocrit method) to obtain an average value. The results are also shown in Table 5.

Details of each test sample used in the test are shown below. The amount of protein in each test sample was measured by the Lowry method (Lowry method), and the amount of decenoic acid was measured by the high performance liquid chromatograph method (HPLC method). The results are shown in Table 4. Furthermore, the amount of royal jelly-derived protein and decenoic acid ingested in terms of rat body weight / kg when each test sample was ingested was calculated. The results are also shown in Table 4.
<Raw Royal Jelly>
In 2006, a commercially available royal jelly from Taiwan was used. Raw royal jelly was diluted 100 times with distilled water (mass (w) / volume (v)) to prepare a test sample, which was subdivided into the amount necessary for daily intake and stored refrigerated.
<Royal jelly fraction>
The royal jelly fraction prepared in Example 4 described later was used. This royal jelly fraction is diluted 500-fold with distilled water (royal jelly fraction A) or 100-fold diluted (royal jelly fraction B) to make a test sample, which is aliquoted into the amount necessary for daily intake. saved.
<Royal jelly-derived protein>
14 kg of raw royal jelly is mixed with 50 kg of deionized water and dispersed uniformly, and concentrated to 10 L using an ultrafiltration membrane (UF membrane, molecular weight cut off 10,000) to obtain the royal jelly-derived protein. Containing fractions were prepared. This was dialyzed twice against 200 L of purified water, desalted, and lyophilized to prepare 55.15 g of powder as a royal jelly-derived protein fraction. 178 mg of this powder was suspended in 120 mL of distilled water to prepare a test sample, which was subdivided into the amount necessary for daily intake and stored refrigerated.

  As is apparent from Table 5, the DAI of rats fed with distilled water during the CE food intake period (breeding period 1) and during the period when the DSS meal was consumed for 8 days (breed period 2) It rose from 1st and became 6.0 on 8th, and watery stool with bloody stool was confirmed, and ulcerative colitis was induced (distilled water group). In the distilled water group, 2 out of 6 animals died due to exacerbation of ulcerative colitis. During the CE food intake period (breeding period 1) and during the period when the DSS diet was fed for 8 days (bred period 2), the DAI of the rats fed with Royal Jelly Fraction B or raw royal jelly as the test sample was DDS intake 4 From day 1 onwards, it was clearly lower than that of the distilled water group, and it was confirmed that these components have an action of suppressing the progression of ulcerative colitis (royal jelly fraction B intake group, Raw royal jelly intake group). In the raw royal jelly intake group, 1 out of 6 animals died due to exacerbation of ulcerative colitis. Even when the royal jelly fraction A or the royal jelly-derived protein was ingested as a test sample during the CE food intake period (breeding period 1) and the DSS meal for 8 days (bred period 2), distilled water intake group Furthermore, DAI changed at a low value, and the hematocrit value showed a value close to the raw royal jelly intake group and the royal jelly fraction B intake group (royal jelly fraction A intake group, royal jelly derived protein intake group). In the royal jelly-derived protein intake group, 2 out of 6 animals died due to exacerbation of ulcerative colitis. When comparing the case where the royal jelly fraction B is ingested with the case where the raw royal jelly is ingested in terms of the strength of the effect of suppressing the progression of symptoms of ulcerative colitis, the royal jelly fraction B ingestion group is distilled water. Compared to the intake group, DAI was significantly lower after 4 days of DSS food intake, and the hematocrit value was also significantly higher, whereas the fresh royal jelly intake group compared to the distilled water intake group 4 Since there was no significant difference in DAI even after the day, and there was no significant difference in hematocrit value, it was judged that the royal jelly fraction B was stronger than the raw royal jelly. This point also correlates well with the fact that none of the mice died when the royal jelly fraction B was ingested, whereas one of the 6 mice died when the raw royal jelly was ingested. It is thought that. Further, as is clear from Table 4, when the intake of decenoic acid when each test sample was ingested was compared, the case where the royal jelly fraction B was ingested was the highest, and the raw royal jelly, the royal jelly fraction A, the royal jelly Since there is a correlation between the treatment of ulcerative colitis and the intake of decenoic acid in the order of the derived protein fractions when each test sample is ingested, the results of Experiment 1 are also considered. The main component of ulcerative colitis treatment effect is decenoic acid. This result also shows that raw royal jelly and its fractions are also useful for the prevention, improvement or treatment of human ulcerative colitis in the same manner as decenoic acid.

  EXAMPLES Hereinafter, although an Example is given and this invention is demonstrated further in detail, the technical scope of this invention should not be construed restrictively at all by this Example.

<Therapeutic agent for ulcerative colitis>
To 0.1 parts by mass of decenoic acid, 99.9 parts by mass of water-containing crystal α, α-trehalose (Hayashibara Shoji Co., Ltd., trade name “Treha”) is homogeneously mixed to prepare a therapeutic agent for ulcerative colitis. Prepared. This product can be granulated, tableted, mixed with other ingredients, or blended into foods and drinks for use in the prevention and treatment of ulcerative colitis. This product can also be displayed with this effect.

<Therapeutic agent for ulcerative colitis>
With respect to 0.2 parts by mass of decenoic acid, 49.8 parts by mass of indigestible dextrin (sold by Matsutani Chemical Co., Ltd., trade name “Fiber Sol 2”), cyclonigerosyl nigerose (Hayashibara Biochemical Co., Ltd.) 50 parts by mass of laboratory manufacture, purity 98 mass (w / w)% or more) were mixed homogeneously to prepare a therapeutic agent for ulcerative colitis. This product can be granulated, tableted, mixed with other ingredients, or blended into foods and drinks for use in the prevention and treatment of ulcerative colitis. This product can also be displayed with this effect.

<Therapeutic agent for ulcerative colitis>
To 1 part by mass of fresh royal jelly, 4 parts by mass of α, α-trehalose was added and dried under reduced pressure to prepare a therapeutic agent for ulcerative colitis. This product can be granulated, tableted, mixed with other ingredients, or blended into foods and drinks for use in the prevention and treatment of ulcerative colitis. This product can also be displayed with this effect.

<Therapeutic agent for ulcerative colitis>
A royal jelly fraction was prepared based on the method described in Example 1 of International Patent Application PCT / JP2008 / 60126. That is, 40 kg of deionized water at 4 ° C. was added to 10 kg of fresh royal jelly (produced in Brazil), and the mixture was uniformly dispersed. Subsequently, this suspension was centrifuged at 10,000 × g using a continuous centrifuge (Model KT-2000G, manufactured by Kubota Corporation), and separated into a supernatant and a precipitate. 6N sodium hydroxide was added to the resulting supernatant to adjust the pH to 7.2, and then filtered through an ultrafiltration membrane (Asahi Kasei sales, trade name “AIP2013”) with a molecular weight cut off of 6,000 daltons. did. The mixture was pushed with a small amount of deionized water and separated into an ultrafiltrate and an ultrafiltrate concentrate. About 40 L of this ultrafiltrate was concentrated to 7 kg by a vacuum concentration method to prepare a royal jelly fraction. This product had a pH of 7.0 and a protein recovery rate of 0.003%, and no protein band was observed by SDS-PAGE. Allergenicity (mouse serum immunized with this product was diluted 10 times and rats were used) (Determined by passive skin anaphylaxis analysis) was not observed. This product contained 20.3 mg / mL of decenoic acid, the mass ratio of decenoic acid to protein was 1: 0.0001, and the mass ratio of hydroxydecenoic acid to nitrogen was 1: 0.15. This product can be used as it is in combination with other ingredients or in foods and drinks for the treatment or prevention of ulcerative colitis.

<Therapeutic agent for ulcerative colitis>
12 parts by mass of a commercially available dextrin (Sanwa Starch Co., Ltd., trade name “Sandeck # 100”) was added to 1 part by mass (converted to solid matter) of the royal jelly fraction prepared in Example 4 and stirred. It melt | dissolved and freeze-dried by the conventional method and prepared the therapeutic agent for ulcerative colitis. This product can be used as it is, granulated, tableted, mixed with other ingredients, or blended with food or drink to prevent or treat ulcerative colitis.

<Therapeutic agent for ulcerative colitis>
150 parts by mass of the decenoic acid-containing powder prepared in Example 1 or the royal jelly fraction powder prepared in Example 4, 45 parts by mass of corn starch, 4 parts by mass of hydroxypropyl cellulose, and 1 part by mass of magnesium stearate The mixture was homogeneously mixed and tableted by a conventional method to produce a therapeutic agent for ulcerative colitis in which each tablet was 200 mg. This product can prevent or treat ulcerative colitis by ingestion.

<Therapeutic agent for ulcerative colitis>
Either 150 parts by mass of the raw royal jelly powder prepared in Example 3 or the royal jelly fraction powder prepared in Example 4, and 45 parts by mass of corn starch and 5 parts by mass of hydroxypropyl cellulose are mixed homogeneously, 300 mg of each was enclosed in a hard capsule to prepare a capsule form ulcerative colitis therapeutic agent. This product can prevent or treat ulcerative colitis by ingestion.

<Therapeutic agent for ulcerative colitis>
Based on the following formulation, a solid ulcerative colitis therapeutic agent was prepared by a conventional method.
(Prescription) (%)
Royal jelly fraction powder prepared by the method of Example 1 49.25
Mulberry leaf powder 10
Barley Wakaba 10
Reduced maltose (sales of Hayashibara Corporation,
Product name "Powder Mabit" 14.5
α-Glucosyl hesperidin (sales by Hayashibara Biochemical Research Co., Ltd., trade name “alpha glucosyl hesperidin”) 15
L-citrulline 1
Fragrance Appropriate amount of pigment Appropriate amount is 100%.

  This product can prevent or treat ulcerative colitis by ingestion.

<Therapeutic agent for ulcerative colitis>
The following ingredients were blended to prepare a therapeutic agent for ulcerative colitis in an oral liquid food form.
(Prescription) (%)
Powdered ulcerative colitis therapeutic agent prepared by the method of Example 2 78
Water-containing crystal maltose (sales by Hayashibara Shoji Co., Ltd., trade name “San Mart”)
L-ascorbic acid 2-glucoside (sales by Hayashibara Shoji Co., Ltd., trade name “ASCO Fresh”) 5
L-carnitine 2.5
L-citrulline 1
α-Lipoic acid 1.5
Lubricant 2
Based on the above formulation, these ingredients were stirred and mixed until homogeneous, and tableted by 0.5 g by a conventional method to prepare tablets.

  This product can prevent or treat ulcerative colitis by ingestion.

<Therapeutic agent for ulcerative colitis>
Based on the following formulation, a drink-type ulcerative colitis therapeutic agent was prepared by a conventional method.
(Prescription) (%)
Decenoic acid 0.1
Carrageenan 1
Xanthan gum 0.15
Locust bean gum 0.15
Maltitol 0.8
Emulsified mint oil 2.6
Propolis extract 0.5
Sucralose 0.3
Citric acid 0.25
Deionized water was added to make the total amount 100%, mixed and dissolved. After sterilization by membrane filtration, 100 g each was enclosed in a brown glass bottle to prepare a therapeutic agent for ulcerative colitis. This product can prevent or treat ulcerative colitis by ingestion.

  This product can prevent or treat ulcerative colitis by ingestion.

<Therapeutic agent for ulcerative colitis>
Based on the following formulation, a drink-type ulcerative colitis therapeutic agent was prepared by a conventional method.
(Prescription) (%)
Powdered ulcerative colitis therapeutic agent obtained by the method of Example 5 35
Anhydrous crystalline maltose (Hayashibara Shoji, trade name "Fine Tooth") 29.5
Powdered egg yolk 19
Nonfat dry milk 20
Sodium chloride 0.44
Potassium chloride 0.185
Magnesium sulfate 0.4
Thiamine 0.001
Coenzyme Q ₁₀ 0.01
Vitamin E acetate 0.06
Nicotinic acid amide 0.004
25 parts by mass of this formulation was uniformly dispersed and dissolved in 150 parts by mass of distilled water, and 150 g each was enclosed in a brown glass bottle to prepare a therapeutic agent for ulcerative colitis. This product can prevent or treat ulcerative colitis by ingestion.

<Therapeutic agent for ulcerative colitis>
Injectable ampules having the following composition were prepared by a conventional method.
Decenoic acid 0.2g
Sodium chloride 0.2g
After sterilizing a proper amount of distilled water, 20 mL each was dispensed into ampoules to prepare a therapeutic agent for ulcerative colitis for injection. This product can be used to prevent or treat ulcerative colitis by administering by parenteral route such as subcutaneous or intramuscular.

  As described above, the therapeutic agent for ulcerative colitis of the present invention containing decenoic acid or a composition containing the same as an active ingredient has an excellent ulcerative colitis treatment or prevention effect. The present invention is an invention that exhibits such remarkable effects, and is a truly significant invention that contributes greatly to the world.

Claims (4)

  A therapeutic agent for ulcerative colitis containing 10-hydroxy-2-decenoic acid as an active ingredient.   The therapeutic agent for ulcerative colitis according to claim 1, wherein 10-hydroxy-2-decenoic acid is formulated in the form of a royal jelly, a royal jelly extract or a royal jelly fraction.   The therapeutic agent for ulcerative colitis according to claim 2, wherein the royal jelly extract is a royal jelly fraction comprising a component having a molecular weight of 6,000 or less.   Select from surfactants, preservatives (antibacterial agents), moisturizers, thickeners, water-soluble polymers, carbohydrates, antioxidants, chelating agents, dyes, fragrances, pH adjusters, vitamins, and additives The therapeutic agent for ulcerative colitis according to any one of claims 1 to 3, comprising one or more selected from the above.