JP2008120719A - Purgative - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a purgative maintaining beneficial intestinal bacteria and diminishing harmful intestinal bacteria while maintaining a purgative effect. <P>SOLUTION: The purgative is formulated from Plantago ovata, senna and/or Aloe ferox and saccharifying bacteria. In one embodiment, the purgative comprises a Plantago ovata seed powder, a senna pod powder, and Bacillus subtilis. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to a laxative comprising plantago obata, senna and / or aloe, and a saccharifying bacterium.

As a constipation therapeutic agent, a laxative containing a swollen armpit component or a colon-irritating armpit component as an active ingredient is known.
The swellable armpit component absorbs moisture in the intestine and swells to form the stool nucleus, and physically stimulates the intestinal wall to exert the armpit action. Natural materials (for example, plantago obata) and synthetic materials (for example, carboxymethylcellulose calcium) are known as swellable armpit components. In addition, a laxative prepared by further blending a butyric acid bacterium or a lactic acid bacterium to impart an intestinal regulating action to the laxative is known (for example, see Patent Documents 1 and 2).
The large intestine stimulating armpit component chemically stimulates the intestinal wall and exerts an armpit action. Natural substances (for example, senna) and synthetic substances (for example, phenovaline) are known as colonic stimulating armpit ingredients. In addition, a laxative prepared by further blending lactic acid bacteria in order to alleviate side effects (for example, reduced action due to continuous use, etc.) caused by a colon-irritating armpit ingredient is known (see, for example, Patent Documents 3 to 4). .

Japanese Patent No. 2726165 JP 7-242557 A JP-A-8-310960 Japanese Patent No. 3010007

In the process of studying combinations of vagina components (swellable and colon-irritating vagina components) and bacteria, the present inventors have found that the combination of these components is beneficial to the composition of the intestinal flora, specifically to the human body. It has been found that it greatly affects the proportion of beneficial bacteria that have an effect and harmful bacteria that have a harmful effect on the human body.
Therefore, an object of the present invention is to provide a laxative that can maintain a laxative action and can make the intestinal flora into a composition advantageous to the human body.

In order to solve the above-mentioned problems, the present inventors have made extensive studies, and as a result, plantago obata, which is a swellable armpit component, senna and / or aloe, which is a colon-irritating armpit component, and a saccharifying bacterium that is a bacterium It has been found that the combination with can maintain beneficial bacteria in the intestine and reduce harmful bacteria while maintaining the axillary action. The present invention has been made based on this finding.
That is, the present invention relates to a laxative containing plantago obata, senna and / or aloe, and saccharifying bacteria.

  The laxative of the present invention can maintain beneficial bacteria in the intestine and reduce harmful bacteria as shown in the examples described later. Therefore, it can be advantageously used as a laxative having added value not found in conventional laxatives.

Hereinafter, the present invention will be described in detail.
The laxative of the present invention is characterized by comprising plantago obata, senna and / or aloe, and saccharifying bacteria.

"Plantago Obata" is a plant with the scientific name Plantago ovata.
In the present invention, any part such as seeds, leaves, stems, roots and the like can be used as long as the swellable armpit component (silium gum) is contained, but seeds are preferable from the viewpoint of swelling. The seed is preferably a mature seed. When using seeds, the whole seeds may be used, or only the seed coats may be used. Seed coat is preferred from the viewpoint of swelling. In addition, the confirmation test of the psyllium gum which is a swellable armpit component can be performed by a color reaction and a swelling test using a failing reagent.
Plantago obata can be used in the form of a crude drug, chopping, powder, extract (extract) and the like. Among these, powders are preferable for preparing laxatives as dosage forms listed in the Japanese Pharmacopoeia, such as granules, powders, and tablets. Various methods well known in the art can be used to process the plantago obata into these forms.
When used as a powder, various methods well known in the art can be used as the production method. For example, the seed coat powder can be produced by using plantago obata seed coat as a powder, sieving using a Japanese bureau No. 42 or a sieve having a finer mesh, and mixing and homogenizing.
Plantago obata is known as a pharmaceutical raw material and can be easily obtained in the market. For example, plantago / Obata seed coat powder (manufactured by Nippon Powder Chemical Co., Ltd.) or plantago / Obata seed powder (manufactured by Nippon Powder Pharmaceutical Co., Ltd.) can be used as seed powder.
The amount of plantago obata is not particularly limited as long as it is an amount capable of maintaining beneficial fungi in the intestine and reducing harmful bacteria while maintaining the axillary action. In the case of the laxative used in the present invention, it is 5 to 99% by mass, preferably 20 to 90% by mass, particularly preferably 30 to 80% by mass, based on the total mass of the laxative.

“Senna” is a plant having the scientific name of Cassia angustifolia Vahl or Cassia acutifolia Delile.
In the present invention, any part such as fruit (senna pod), leaves, stems, roots and the like can be used as long as it contains a large intestine stimulating armpit component (sennoside), but senna pod is preferable from the viewpoint of effectiveness and safety. . In addition, the confirmation test of sennoside can be performed according to the description of 15th revision Japanese Pharmacopoeia explanation book, Yodogawa Shoten, 2006 D-387-D-393.
Senna can be used in the form of a crude drug, chopping, powder, extract (extract) and the like. Among these, powders are preferable for preparing laxatives as dosage forms listed in the Japanese Pharmacopoeia, such as granules, powders, and tablets. Various methods well known in the art can be used to process the senna into these forms.
When used as a powder, various methods well known in the art can be used as the production method. For example, the senna pod powder can be produced by using senna pod as a powder, sieving using a Japanese bureau No. 42 or a sieve having a finer mesh, and mixing and homogenizing.
Senna is known as a pharmaceutical raw material and can be easily obtained in the market. For example, Sennapod powder (manufactured by Nippon Powder Chemical Co., Ltd.) can be used as Sennapod powder.

Senna may be used as a sennoside simple substance that is a colon-irritating armpit component. Sennoside (chemical name: Dihydro-dirheinanthrone glucoside, molecular formula: C ₄₂ H ₃₈ O ₂₀ , molecular weight: 862.74) is a substance commonly used in laxatives as a colon-irritating armpit ingredient and is also known as the main armpit ingredient in senna and diaoh It has been. It is hydrolyzed by intestinal bacteria and metabolized to the active substance, lane anthrone, and exerts a sputum activity on the living body. Sennoside includes sennoside A and sennoside B, which are optical isomers at the 10-10 ′ position. The structural formula is shown below.

In the present invention, either sennoside A or sennoside B, or a mixture thereof can be used. Also, it can be used in the form of a pharmaceutically acceptable salt, and a calcium salt is particularly preferred.
Sennoside is known as a pharmaceutical raw material and can be easily obtained in the market. For example, sennoside calcium S (manufactured by Alps Yakuhin Kogyo Co., Ltd.), which is a calcium salt of sennosides A and B, can be used.

“Aloe” is a plant having the scientific name Aloe ferox Miller, or a hybrid plant (Liliaceae) of Aloe ferox Miller and Aloe africana Miller or Aloe spicata Baker.
In the present invention, any part such as leaves, stems, roots and the like can be used as long as it contains a large intestine stimulating armpit component (barvaloin), but leaves are preferred from the viewpoint of the content of valovaroin. In addition, the confirmation test of barbaroin can be performed in accordance with the description of the 15th revision Japanese Pharmacopoeia Manual, Yodogawa Shoten, 2006 D-22 to D-27.
Aloe can be used in the form of a crude drug, chopping, powder, extract (extract) and the like. Among these, powders and extracts (extracts) are preferable in preparing laxatives as dosage forms listed in the Japanese Pharmacopoeia, such as granules, powders, and tablets. The extract (extract) may be in the form of a dry powder or a soft liquid (paste). Various methods well known in the art can be used to process the aloe into these forms.
When using as an extract (extract), as a manufacturing method, various methods well-known in the said technical field can be used. For example, an aloe leaf extract (extract) can be produced by heating and extracting aloe leaves with purified water and then concentrating with an evaporator, or by further drying and pulverizing them. .
Aloe is known as a pharmaceutical raw material and can be easily obtained in the market. For example, an aloe soft extract (manufactured by Nippon Flour Pharmaceutical Co., Ltd.) can be used as the aloe extract (extract).

In the present invention, senna or aloe may be used alone, or senna and aloe may be used in combination.
When senna or aloe is used alone, the amount of the senna or aloe is not particularly limited as long as it is an amount capable of maintaining beneficial fungi in the intestine and reducing harmful bacteria while maintaining the gazing action. However, for example, in the case of a laxative used for humans, it is 0.1 to 50% by mass, preferably 0.2 to 30% by mass, particularly preferably 0.5 to 20% by mass, based on the total mass of the laxative. is there.
When senna and aloe are used in combination, each mass of senna and aloe is set to the blending amount in the case of single use described above.
When sennoside alone is used as the senna, the amount of the sennoside is not particularly limited as long as it maintains an antifungal action while maintaining beneficial bacteria in the intestine and reducing harmful bacteria. For example, in the case of a laxative used for humans, it is 0.01 to 10% by mass, preferably 0.05 to 5% by mass, particularly preferably 0.1 to 3% by mass, based on the total mass of the laxative. .
When the sennoside simple substance and aloe are used in combination, the respective masses of the sennoside simple substance and the aloe are set to the blending amounts in the case of the single use described above.

Saccharifying bacteria are bacteria belonging to Bacillus subtilis, Bacillus mesentericus and Bacillus polyfermenticus. The confirmation test for saccharifying bacteria can be performed according to the description of the Japanese Pharmacopoeia Pharmaceutical Standards (supervised by the Japanese Association of Officials), Jiho Co., Ltd., pages 415-416. Among these, Bacillus subtilis is preferable from the viewpoint of convenience in obtaining raw materials.
As Bacillus subtilis, natto bacteria are preferable.
The saccharifying bacterium can be used in any pharmaceutically acceptable form, for example, a dry spore powder or a dry viable cell powder. Among these, dry spore powder is preferable from the viewpoint of stability. Various methods well known in the art can be used for processing into these forms. For example, when it is used as a dried spore powder, it can be produced by culturing the bacterium until it is sufficiently spore-formed on an agar medium, and then collecting and drying. Further, in order to facilitate the adjustment of the saccharifying bacterium concentration in the laxative, the saccharifying bacterium may be used as a mixture obtained by mixing with a pharmaceutically acceptable carrier, for example, Japanese Pharmacopoeia potato starch.
Saccharifying bacteria are known as pharmaceutical raw materials and can be easily obtained in the market. For example, Bionutmin (manufactured by Meguro Laboratories Co., Ltd.), which is a mixture of dried spore powder derived from Bacillus subtilis BN strain and Japanese Pharmacopoeia potato starch, can be used.
The amount of the saccharifying bacterium is not particularly limited as long as it is an amount that can maintain beneficial bacteria in the intestine and reduce harmful bacteria while maintaining the gazing action, but it is used in humans. In the case of an agent, it is 10 ⁴ to 10 ¹⁰ , preferably 10 ⁵ to 10 ⁹ , particularly preferably 10 ⁶ to 10 ^9, per 1 g of the laxative.
When a plurality of types of saccharifying bacteria are used in combination, the total number of saccharifying bacteria is set to the blending amount in the case of single use described above.

The laxative of the present invention may contain lactic acid bacteria as an optional component for the purpose of further intestinal regulation. Specific examples include Lactobacillus acidophilus and other Lactobacillus genera, Enterococcus faecalis and other Enterococcus genera, and Bifidobacterium longum and other bifidobacterium longum. Examples include the genus Fidobacterium and Bacillus coagulans.
Lactic acid bacteria can be used in the form of dried spore or dried viable cell powder, as in the above-mentioned saccharifying bacteria.
Lactic acid bacteria are known as pharmaceutical raw materials and can be easily obtained on the market. For example, Biodiasmin F-100 (manufactured by Amano Enzyme Co., Ltd.) can be used as Enterococcus faecalis in a dry viable cell powder state.
For example, in the case of a laxative used for humans, the blending amount of lactic acid bacteria is 10 ⁴ to 10 ¹² , preferably 10 ⁵ to 10 ¹¹ , particularly preferably 10 ⁶ to 10 ¹⁰ per 1 g of the laxative.

  The laxative of the present invention is preferably administered orally, and it is possible to take a mixture of each component according to the present invention, but taking into account ease of taking, It is preferable to make the dosage form suitable for oral administration such as fine granules, granules, pills, tablets, capsules, syrups and the like. In the present invention, powders, fine granules, granules, and pills are preferred as dosage forms.

  Formulation can be performed by a known method. For example, plant agobata, senna and / or aloe, and saccharifying bacteria (optional components) may be added with known adjuvant ingredients and formulation additives as appropriate, for example, described in the 15th revision of the Japanese Pharmacopoeia By the conventional methods, it can be formulated into dosage forms suitable for oral administration such as powders, fine granules, granules, pills and the like.

  As active ingredients, vitamins (nicotinamide, pyridoxine hydrochloride, calcium pantothenate), antifoaming agent (dimethylpolysiloxane), herbal medicines (Ketsumeishi, Yokuinin, Fennel, Keihi, Menthol, Homika), dry yeast, etc. Can be mentioned.

  Examples of the formulation additive include an excipient, a corrigent, a binder, a colorant, and a lubricant.

  Examples of the excipient include erythritol, xylitol, trehalose, low-substituted hydroxypropylcellulose, mannitol, lactose, sucrose, starch, and crystalline cellulose.

  Examples of the corrigent include cacao powder, ascorbic acid, aspartame, acesulfame potassium, stevia, sucralose, various powdered fragrances, mint oil, L-menthol, peppermint and the like.

  Examples of the binder include hydroxypropylcellulose, hydroxypropylmethylcellulose, polyvinylpyrrolidone, polyvinyl alcohol and the like.

  Examples of the colorant include iron sesquioxide, yellow iron sesquioxide, black iron oxide, edible yellow No. 5 dye, edible red No. 3 dye, edible blue No. 2 dye, edible lake dye, and titanium oxide.

  Examples of the lubricant include light anhydrous silicic acid, magnesium stearate, calcium stearate, talc, sucrose fatty acid ester, glycerin fatty acid ester and the like.

  The formulation additive may be added in an appropriate step as appropriate when the pharmaceutical composition of the present invention is produced (formulated).

Specific formulation examples A to D of the laxative of the present invention are shown below, but the present invention is not limited thereto.

  The laxative of the present invention can be administered orally depending on the dosage form. The dosage usually varies depending on the weight of the patient, the nature of the disease and the condition, but when used for an adult, it is 1 to 50 g per day, preferably 5 to 20 g.

The laxative of the present invention can maintain beneficial bacteria in the intestine and reduce harmful bacteria while maintaining the laxative action.
Beneficial bacteria (sometimes called good bacteria) are beneficial to the human body among the bacteria that form the intestinal flora, ie vitamin synthesis, assistance in digestion and absorption, suppression of enteric harmful bacteria, immune activation, foreign It refers to a bacterium having an action such as elimination of pathogenic bacteria. Specifically, Bifidobacterium longum, Bifidobacterium breve, Bifidobacterium adolescentis, Bifidobacterium bifidum , Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus reuteri, Enterococcus faecalis and the like.
Harmful bacteria (sometimes called bad bacteria) refers to bacteria that have intestinal flora-forming effects that are harmful to the human body, such as intestinal rot, production of carcinogens, and toxin production. . Specific examples include Clostridium perfringens (also referred to as Clostridium perfringens), Escherichia coli, and Bacteroides fragilis.
Although the present invention is not limited to a specific theory, the laxative of the present invention can maintain beneficial fungi in the intestine and can reduce harmful bacteria while maintaining the laxative action. This is probably because the combination of antibacterial components contained in each component acts to maintain beneficial bacteria in the intestine and to reduce harmful bacteria.
EXAMPLES Hereinafter, the present invention will be specifically described with reference to examples, but the present invention is not limited to the examples.

The armpit activity test This test was conducted to confirm the armpit action of the armpit agent of the present invention. Three types of laxatives having the compositions described in Table 1 were used in the test.
Plantago obata seed powder (manufactured by Nippon Powdery Chemical Co., Ltd.), which is plantago obata seed powder, was used as plantago obata.
As the senna, Sennapod powder (manufactured by Nippon Powder Chemical Co., Ltd.), which is sennapod powder, was used.
As a saccharifying bacterium, a dried spore powder derived from Bacillus subtilis BN strain is mixed with Japanese pharmacopoeia potato starch, and a mixture prepared so that the number of viable bacteria in 1.0 g is 1 × 10 ⁹ to 1 × 10 ¹⁰ Bionatmin (Meguro Laboratories Co., Ltd.) was used (the amount of saccharifying bacteria in Table 1 is shown as the amount of the mixture).

Table 1. Laxative composition (mg)

A suspension obtained by suspending each of these components in 10 mL of water was orally administered to Wistar male rats (8 weeks old) (4 rats for each laxative) at a dose of 10 mL / kg. A control group (4 animals) was orally administered 10 mL / kg water. The number of feces in each rat up to 10 hours after administration was observed separately for soft feces and diarrhea feces.
The observation results were summarized as the number of effective feces per rat (average effective fecal number). The number of effective feces means the number of feces that are recognized to be excreted by the action of the laxative, and was calculated by “observed feces number−feces of control group”. For each group, the average number of effective feces was determined for each of soft feces and diarrhea feces. The results are shown in Table 2 and FIG.

Table 2. Average effective feces

  From the experimental results, it was confirmed that the laxative of Example 1 containing plantago obata, senna and saccharifying bacteria has a laxative action. Moreover, in the laxative of Example 1, diarrhea feces decreased and soft feces increased compared to the laxative of Comparative Example 2 consisting only of senna. This indicates that the laxative of Example 1 has a mild axillary action.

Test for effects on beneficial and harmful bacteria in the intestine This test was conducted to confirm that the laxative of the present invention maintains beneficial bacteria in the intestine and reduces harmful bacteria.
In the test, 11 types of test media (Comparative Examples 3 to 6 and Examples 2 to 5) obtained by adding the laxative ingredients listed in Table 3 to the basic medium were used to remove beneficial or harmful bacteria in an intestinal environment mimicking environment. And by observing the time course of the number of each bacteria.
Plantago obata seed powder (manufactured by Nippon Powdery Chemical Co., Ltd.), which is plantago obata seed powder, was used as plantago obata.
As the senna, Sennapod powder (manufactured by Nippon Powder Chemical Co., Ltd.), which is sennapod powder, was used.
As the aloe, an aloe extract (extract), an aloe soft extract (manufactured by Nippon Powder Chemical Co., Ltd.), was used.
Sennoside calcium S (manufactured by Alps Yakuhin Kogyo Co., Ltd.) was used as a sennoside simple substance.
As a saccharifying bacterium, a dried spore powder derived from Bacillus subtilis BN strain is mixed with Japanese pharmacopoeia potato starch, and a mixture prepared so that the number of viable bacteria in 1.0 g is 1 × 10 ⁹ to 1 × 10 ¹⁰ Bionatmin (Meguro Laboratories Co., Ltd.) was used (the amount of saccharifying bacteria in Table 3 is shown as the amount of the mixture).
Daio dry extract (manufactured by Nippon Powdery Chemical Co., Ltd.) was used as a dio that is a large intestine stimulating armpit ingredient for a comparative experiment.

単位(mg/10mL)：試験培地10mLあたりの各成分のmg数。

Table 3

Unit (mg / 10 mL): mg of each component per 10 mL of test medium.

上記成分を混合後、高圧蒸気滅菌（121℃、20分）したものを使用した。 Basic medium

After mixing the above components, one that had been autoclaved (121 ° C., 20 minutes) was used.

Test of beneficial bacteria Bifidobacterium longum (JCM number: JCM1217) and Bifidobacterium breve (JCM number: JCM1192) purchased from RIKEN BioResource Center were used as beneficial bacteria in the intestine.
First, a test medium containing a laxative component was maintained in an environment mimicking the small intestine, and saccharified bacteria in the medium were grown. Specifically, various test media are kept under microaerobic conditions (oxygen concentration of about 10%) using a microaerobic culture kit (Aneropack microaerobic (Mitsubishi Gas Chemical Co., Ltd.)) (35 ° C, 8% Time) and saccharified bacteria were cultured.
Pre-culture (anaerobic conditions, 35 ° C., 24 hours) using the GAM bouillon (Nissui Pharmaceutical Co., Ltd.) and anaerobic culture kit (Aneropack Kenki (Mitsubishi Gas Chemical Co., Ltd.)) The beneficial bacteria were inoculated at a concentration of 10 ⁸ CFU / mL and anaerobically cultured (35 ° C., 72 hours) in an anaerobic culture kit (Aneropack Kenki (manufactured by Mitsubishi Gas Chemical Co., Ltd.)). The culture was sampled after 72 hours of anaerobic culture.
The sampled culture was subjected to anaerobic culture (35 ° C., 72 hours) in a TOS propionate agar medium (manufactured by Yakult Pharmaceutical Co., Ltd.) which is a selective medium for beneficial bacteria, and then the viable count of beneficial bacteria was measured.
These steps were performed for various beneficial bacteria.

Test for harmful bacteria Clostridium perfringens (JCM number: JCM1290) purchased from RIKEN BioResource Center was used as harmful bacteria in the intestine.
First, a test medium containing a laxative component was maintained in an environment mimicking the small intestine, and saccharified bacteria in the medium were grown. Specifically, various test media are maintained under microaerobic conditions (oxygen concentration of about 10%) using a microaerobic culture kit (Aneropack microaerobic (Mitsubishi Gas Chemical Co., Ltd.)) (35 ° C, 8 hours) And saccharified bacteria were cultured.
Pre-culture (anaerobic conditions, 35 ° C., 24 hours) using the GAM bouillon (Nissui Pharmaceutical Co., Ltd.) and anaerobic culture kit (Aneropack Kenki (Mitsubishi Gas Chemical Co., Ltd.)) The harmful bacteria were inoculated at a concentration of 10 ⁴ CFU / mL and anaerobically cultured (35 ° C., 72 hours) in an anaerobic culture kit (Aneropack Kenki (manufactured by Mitsubishi Gas Chemical Co., Ltd.)). The culture was sampled after 72 hours of anaerobic culture.
The sampled culture was subjected to anaerobic culture (46 ° C., 24 hours) in a selective medium for harmful bacteria having the following composition, and then the viable count of harmful bacteria was measured.

上記成分を混合し、高圧蒸気滅菌（121℃、10分）した後に、下記試薬を添加したものを使用した。 Harmful bacteria selection medium

The above components were mixed, autoclaved (121 ° C., 10 minutes), and then added with the following reagents.

^※緩衝チオグリコール酸Na溶液は、4gのリン酸水素二カリウム、2gの炭酸ナトリウム及び4gのチオグリコール酸ナトリウムを100mLの精製水に溶解し、ろ過滅菌したものを使用した。

^{* The} buffered sodium thioglycolate solution was prepared by dissolving 4 g of dipotassium hydrogen phosphate, 2 g of sodium carbonate, and 4 g of sodium thioglycolate in 100 mL of purified water and sterilizing by filtration.

生菌数の単位：CFU/mL The results are shown in Table 4.
Table 4

Viable count unit: CFU / mL

  Furthermore, the graphs of Table 4 for beneficial bacteria and harmful bacteria are shown in FIG. 2 (beneficial bacteria) and FIG. 3 (harmful bacteria).

About Bifidobacterium longum (beneficial bacteria), the number of bacteria at the time of inoculation (10 ⁸ CFU / mL) was almost maintained in the presence of the laxative of Examples 2-5. On the other hand, in the presence of the laxatives of Comparative Examples 3, 5 and 6, the number of bacteria decreased compared to the time of inoculation.

  For Bifidobacterium breve (beneficial bacteria), the number of viable bacteria was greatly reduced in the presence of the laxatives of Comparative Examples 5 and 6.

Regarding Clostridium perfringens (harmful bacteria), in the presence of the laxatives of Examples 2 to 5, the number of bacteria was significantly reduced from the number of bacteria at the time of inoculation (10 ⁴ CFU / mL). On the other hand, in the presence of the laxative of Comparative Examples 3 and 4, the number of bacteria increased from the number at the time of inoculation.

  The above results indicate that only the laxatives of the examples were able to maintain the number of beneficial bacteria and reduce harmful bacteria.

Formulation Example A laxative having the following composition (corresponding to the above Formulation Example A) was produced according to the following procedure.

(1) Plantago / Obata seed powder, Plantago / Obata seed powder (manufactured by Nippon Flour Pharmaceutical Co., Ltd.) 10,840 g as Plantago / Obata, and Sennapod powder (manufactured by Nippon Powder Chemical Co., Ltd.) 2,480 g as senna Nicotinamide (Organic Synthetic Chemical Co., Ltd.) 6.25 g, Erythritol (Niken Kasei Co., Ltd.) 450 g, Low-substituted hydroxypropyl cellulose (Shin-Etsu Chemical Co., Ltd.) 875 g, Kakao powder (Daito Kakao Co., Ltd.) 500 g, ascorbic acid (manufactured by Merck) 180 g, hydroxypropylcellulose (manufactured by Nippon Soda Co., Ltd.) 150 g, iron sesquioxide (manufactured by Kasei Kasei Co., Ltd.) 110 g, kneading machine (manufactured by Dalton Co., Ltd., KDA) -100), the raw materials were mixed at a constant speed for 60 minutes. To this, 12,500 g of 50% (W / W) ethanol was poured and kneaded at a constant speed for 10 minutes. The obtained kneaded product was subjected to extrusion granulation using a screen having an aperture of 1.0 mm. After drying at 90 ° C., the obtained dried product was sieved with a sieve having an opening of 1.0 mm to obtain granulated granules.
(2) 75 g of biodiasmin F-100 (Dential live cell powder of Enterococcus faecalis, manufactured by Amano Enzyme Co., Ltd.) as lactic acid bacteria, 125g mixed with pharmacopoeia potato starch and adjusted so that the number of viable bacteria in 1.0g is 1 x 10 ⁹ to 1 x 10 ¹⁰ (manufactured by Meguro Laboratories, Inc.), aspartame (manufactured by Ajinomoto Co., Inc.) 50 g, 15 g of vanilla flavor (manufactured by Takasago Fragrance Co., Ltd.) and 7.5 g of light anhydrous silicic acid (manufactured by Freund Sangyo Co., Ltd.) were mixed with 40 mesh sieve to prepare a trituration.
(3) Using the granule obtained in (1) and the trituration obtained in (2), as a weight ratio in four sachets, mixing them with 11,782 mg of granule and 218 mg of trituration, the resulting granule The agent was filled into an aluminum sachet at 3,150 mg.

  The present invention can be used as a laxative.

FIG. 1 is a graph showing the average effective fecal count. FIG. 2 shows the viable count of beneficial bacteria after 72 hours of culture. FIG. 3 shows the viable count of harmful bacteria after 72 hours of culture.

Claims (8)

  A laxative containing plantago obata, senna and / or aloe, and saccharifying bacteria.   The laxative according to claim 1, comprising plantago obata seed powder as plantago obata.   The laxative according to claim 1, comprising senna pod powder as a senna.   The laxative according to claim 1, comprising sennoside as a senna.   The laxative according to claim 1, comprising an aloe extract as the aloe.   The laxative according to claim 1, comprising Bacillus subtilis as a saccharifying bacterium.   A laxative comprising plantago obata seed powder, senna pod powder, and Bacillus subtilis.   A laxative containing plantago obata seed powder, sennoside alone, and Bacillus subtilis.

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