JP2516542B2 - Laxative-containing laxative composition - Google Patents

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a laxative containing lactic acid bacterium in which lactic acid bacterium is stably and homogeneously mixed with plantago ovata seed coat.

[0002]

2. Description of the Related Art Plantago ovata seed coat is listed as a swelling laxative component in the standard of laxatives in the pharmaceutical manufacturing guidelines.

[0003] On the other hand, lactic acid bacteria have been approved as a component of live intestinal bacteria in laxatives, and have been mixed with suitable excipients such as starch, lactose, sucrose, or a mixture thereof, which is a non-Japanese Pharmacopoeia It is also listed as lactomin in the component specifications.

Therefore, it is significant to combine these two components and provide a safe and mild laxative as a medicine.

However, when lactic acid bacteria are mixed and kneaded with an excipient which is a general method for producing granules and the granulation operation is carried out, the bacteria are killed. Therefore, lactic acid bacteria are stably mixed with other active laxatives. It is difficult to put a laxative preparation containing lactic acid bacteria, which has excellent properties, on the market as a drug, and in particular, there has been no combination of lactic acid bacteria and plantago ovata seed coat.

On the other hand, it is considered that a stable composition can be obtained by simply mixing lactic acid bacteria with Plantago ovata seed coat in order to prevent the death of the lactic acid bacteria during production. However, this method also has a large difference in physical properties between plantago ovata seed coat and lactic acid bacterium, so that it is possible to prevent the killing of the bacterium by simply mixing them, but it is difficult to obtain a homogeneous preparation, and the feeling of ingestion is not good either. . Moreover, segregation occurs during transportation or when a packaging material is produced, which is not preferable in terms of the quality of the drug. Further, it is known that plantago ovata seed coat and purified sucrose are simply granulated, and a mixture of this and lactic acid bacteria has high stability and a good feeling to take. However, since the surface of this product is not rough enough to hold fine particles, it is difficult to uniformly hold fine particles such as lactic acid bacteria, and when the product is transported or a packaging material is produced, segregation occurs, which is preferable in terms of pharmaceutical quality. Absent.

[0007]

SUMMARY OF THE INVENTION Therefore, an object of the present invention is to provide a lactic acid bacterium-containing purgative drug in which lactic acid bacterium is stably and uniformly blended with plantago ovata seed coat.

[0008]

In view of such circumstances, the inventors of the present invention have conducted extensive studies, and as a result, if sugars were attached to the surface of Plantago ovata seed coat using an aqueous solvent, the surface was modified. Thus, the inventors have found that a lactic acid bacterium-containing cathartic composition which is easy to attach to lactic acid bacterium and is homogeneous, stable, and having a good feeling on ingestion can be obtained.

That is, the present invention provides a cathartic composition comprising a lactic acid bacterium and an amorphous granule obtained by adhering a saccharide in the presence of an aqueous solvent on the surface of a plantago ovata seed coat. is there.

The saccharide used in the present invention is not particularly limited as long as it can be used for oral administration, but especially when sucrose, glucose, mannitol, xylitol, reduced maltose, lactose or a mixture thereof is used, it has an excellent phlegm feeling. A pharmaceutical composition can be obtained.

In the present invention, the following method is exemplified as a method for attaching saccharides to the surface of the planta ovata seed coat. (1) A method in which an aqueous solvent is added to a plantago ovata seed coat to moisten it, and then saccharides are added to the granules with stirring. (2) A method in which an aqueous solvent is added to a mixture of plantago-Obata seed coat and saccharides and the mixture is stirred and granulated. (3) A method of spray granulating plantago and ovata seed coats with a saccharide solution.

[0012] The amount of sugar attached to the seed coat of plantago ovata varies depending on the type of sugar.
It is preferable to add 20 to 200% by weight of saccharides to 1 part by weight of ovata.

After the saccharides have been attached to the seed coat in this way, if necessary, drying, sizing and the like are performed. The obtained irregularly shaped granules have a roughened surface, which makes it easy to retain fine particles.Stable by simply mixing lactic acid bacteria or slightly moistening the irregularly shaped granules and then mixing with lactic acid bacteria, It is possible to obtain a laxative composition containing a lactic acid bacterium, which is highly effective, has excellent homogeneity, and has a good feeling of ingestion.

The lactic acid bacterium may be mixed by adding the lactic acid bacterium to the amorphous granule and mixing them with a mixer. However, the irregular granule is sprayed with water to slightly wet it, and then the lactic acid bacterium is added and mixed. More preferable is a method of mixing by a machine and immediately drying.

The composition of the present invention thus obtained has the shape of flakes and particles and can be used as it is as a pharmaceutical preparation. In addition to this, a stomachic ingredient of crude drug, vitamin B ₆ and nicotinic acid amide are further added. It is possible to enhance the usefulness as a cathartic by adding vitamins such as. It is also possible to add a corrigent, an excipient, etc., and use it as a granule, a liquid preparation prepared at the time of use, or the like.

[0016]

The laxative composition of the present invention comprises plantago
Since the surface of ovata seed coat is roughened by sugar,
The lactic acid bacterium is stably retained, and even if it is packaged, segregation is small, and the formulation is stable and homogeneous. Furthermore, the composition of the present invention has the shape of flake-shaped particles and strips, has a good texture and is extremely excellent in ingestion, and thus contributes to the improvement of compliance.

[0017]

The present invention will be described in detail below with reference to examples, but the present invention is not limited thereto. Hereinafter, laxative compositions containing lactic acid bacteria were produced as shown in Examples 1 to 3 and Comparative Examples 1 and 2. In addition, lactic acid bacterium is Biodiasmin F-100 (manufactured by Amano Pharmaceutical Co., Ltd.)
X10 ⁸ pieces were used).

Example 1 350 g of plantago ovata seed coat was placed in a granulator (manufactured by Paulec Co., Ltd., FM-VG10 type vertical granulator), 50 ml of water was added to moisten the mixture, and 250 g of purified sucrose was added to the granulation with stirring. After drying and drying, the particles were sized to obtain 540 g of an irregular granule. 60g of this irregular shaped granule
0.6 g of biodiasmin F-100 was added to and mixed with the mixture to obtain a laxative composition containing lactic acid bacteria.

Example 2 350 g of plantago ovata seed coat and 250 g of refined white sugar
Was placed in a granulator (manufactured by Paulec Co., Ltd., FM-VG10 type vertical granulator), 40 ml of water was added, and the mixture was granulated by stirring, dried, and then sized to give an amorphous granule 560.
g was obtained. To 60 g of this irregularly shaped granule, 0.6 g of biodiasmin F-100 was added and mixed to obtain a laxative composition containing lactic acid bacteria.

Example 3 120 g of the amorphous granule obtained in Example 2 was sprayed with 3 ml of water to wet it, and then Biodiasmin F-100 1.2.
g was added and mixed, and immediately dried to obtain a lactic acid bacterium-containing cathartic composition.

Comparative Example 1 100 g of plantago ovata seed coat and 1.7 g of biodiasmin F-100 were mixed with a mixer to obtain a laxative composition containing lactic acid bacteria.

Comparative Example 2 200 g of plantago ovata seed coat, 143 g of purified sucrose and 3.4 g of biodiasmin F-100 were taken in a granulator (manufactured by Paulec Co., Ltd., FM-VG10 type vertical granulator), and 40 ml of water was added. After granulating with stirring, drying and sizing, a purgative composition containing lactic acid bacteria was obtained.

Test Example 1 With respect to the laxative bacterium-containing cathartic compositions obtained in Examples 1 to 3 and Comparative Examples 1 and 2, the number of viable lactic acid bacteria at the time of production and after storage at 40 ° C. for 3 months was measured. Table 1 shows the results.

[0024]

[Table 1]

As is clear from Table 1, according to the present invention, lactic acid bacteria were not killed and were stable at the time of production and after storage at 40 ° C. for 3 months. In Comparative Example 2 in which lactic acid bacteria were kneaded together with Plantago ovata seed coat and granulated, abrupt death of the bacteria was observed during production.

Test Example 2 With respect to the laxative bacterium-containing cathartic compositions obtained in Examples 1 to 3 and Comparative Examples 1 and 2, the degree of adhesion of lactic acid bacterium to an amorphous granule was measured. That is, 10 g of a laxative composition containing lactic acid bacteria
Was put on a 100-mesh (150 μm) sieve and lightly tapped to determine the amount of lactic acid bacteria that passed through the sieve, and the non-adhesion rate was calculated. The results are shown in Table 2.

[0027]

[Table 2]

As shown in Table 2, according to the present invention, the non-adherence rate of lactic acid bacteria can be suppressed to 10% or less by the surface modification of the plantago and ovata seed coat. On the other hand, in Comparative Example 1, the adhesion of plantago ovata seed coat and lactic acid bacterium is insufficient, and in Comparative Example 2, lactic acid bacterium is almost adhered, but the stability is not good as shown in Test Example 1. .

Test Example 3 With respect to the laxative bacterium-containing cathartic composition obtained in Examples 1 to 3 and Comparative Examples 1 and 2, the feeling of ingestion was examined. The results are shown in Table 3.

[0030]

[Table 3]

As shown in Table 3, the composition according to the present invention has an excellent feeling of ingestion and contributes to the improvement of compliance.

Test Example 4 Examples 1 and 2, which were excellent in stability of lactic acid bacteria in Test Example 1,
For 3 and Comparative Example 1, stick packaging was performed and segregation was examined. That is, 1.5 g of each lactic acid bacterium-containing purgative composition was pillo-packed in a stick having a length of 10 cm and a width of 2 cm, and then the viable cell count of the lactic acid bacterium in one package was measured to determine the content uniformity. The results are shown in Table 4.

[0033]

[Table 4]

According to the present invention, in Examples 1 to 3, the lactic acid bacteria were all uniformly packaged, and a packaging agent having excellent quality was produced. Particularly in Example 3, a packaging material having high uniformity could be obtained. On the other hand, in the comparative example, variation among the packages was observed, and the content uniformity was not sufficient. These results were correlated with the adhesiveness of the lactic acid bacteria obtained in Test Example 2.

Claims (1)

(57) [Claims] 1. A laxative composition comprising a lactic acid bacterium and an amorphous granule obtained by adhering a saccharide in the presence of an aqueous solvent on the surface of a plantago / Obata seed coat.