JP2613539B2 - Gastrointestinal drug - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

The present invention relates to improved compositions of gastrointestinal drugs. More specifically, the present invention relates to a composition of a gastrointestinal drug that is effective in treating gastrointestinal-related pathologies in a period from active to scarring.

[0002]

2. Description of the Related Art Conventionally, gastrointestinal drugs have been prepared according to the purpose, based on the efficacy of the compounding ingredients, according to the manufacturing approval criteria under the Pharmaceutical Affairs Law,
It is classified into mucosal repair agents, antacids, digestives, intestinals, antidiarrheals, and analgesics and antispasmodics.

[0003] These conventional gastrointestinal drugs are, in Western medicine, a protective factor-promoting type for promoting repair and preventing recurrence in the repair stage or scar stage of a disease state, and antacid, analgesic, and antispasmodic in an active condition. It is classified into an aggressive factor suppressing type that aims to act. The protective factor promoting type includes a stomachic and a mucosal repair agent, and an antacid and an analgesic and antispasmodic are of the aggressive factor suppressing type. In addition, the conventional gastrointestinal drugs have a compounding rule determined by the above-mentioned production approval criteria, and are limited to any of the above-mentioned medicinal groups or antacids, stomach, digestion, and intestinal regulation of two or more. .

[0004] In addition, many crude drugs have a wide variety of medicinal properties with one crude drug component. However, oak and carrot are recognized as stomach-reducing agents, liquorice as a mucosal repair agent, and peonies as an analgesic and antispasmodic agent. I have.

[0005]

Conventionally, however, the combination rule based on the above-mentioned production approval standard has, in principle, prohibited the combination of a stomachic with an analgesic and antispasmodic, especially for crude drugs, so that both of these components are included. There were no gastrointestinal drugs. For this reason, it was not possible to combine the effects of both protective factor promotion and aggressive factor suppression with gastrointestinal drugs. More specifically, the intrinsic efficacy of stomachic drugs is heartburn,
It was limited to medicinal effects such as anorexia (decreased appetite), sagging stomach, and nausea, but it was not combined with effects such as stomach pain, abdominal pain, stomach and abdominal discomfort.

Accordingly, the present invention has both effects of promoting a protective factor and suppressing an aggressive factor, and can exert its drug effect in a wide period from the active stage to the repair stage and the scar stage of the symptoms. It is an object of the present invention to provide a gastrointestinal drug comprising a crude drug component in a composition that can be safely produced without side effects and that can be approved for production by the aforementioned Pharmaceutical Affairs Law.

[0007]

Means for Solving the Problems In order to achieve the above object, the present inventors have conducted intensive studies and as a result obtained a gastrointestinal drug having the following composition. That is, it is characterized by containing psyllium, carrot, liquorice and peonies as essential components .

[0008] These crude drug components can be blended by uniformly mixing in a fine powder state. In this case, the blending ratio of these crude drug components is such that carrots 25-45 parts by weight, liquorice 50-75 parts by weight, and peonies are used for 100 parts by weight of psyllium in order to maximize their respective medicinal effects.
Preferably it is 50 to 60 parts by weight.

[0009] The dosage form of the gastrointestinal drug of the present invention is
In addition to powders, existing ones such as granules and tablets can be used. Therefore, in this case, the gastrointestinal drug of the present invention includes
Incorporates excipients, disintegrants, binders, etc. suitable for the mold
Can be In addition, colorants, coloring aids, flavor components
Which optional ingredients are blended as long as the effects of the present invention are not hindered
You can also.

In the method for producing the gastrointestinal drug of the present invention, for example, in the case of pills, the crude drug components of oak, carrot, liquorice and peonies are finely powdered, and a binder, a disintegrating agent, etc. And uniformly mixed, a binder solution is poured into the mixture, and the mixture is kneaded. Thereafter, the mixture can be obtained as a pill through the steps of rounding, drying, sizing, and coating.

[0011]

In the present invention, the following effects are produced.
That is, according to the gastrointestinal drug of the present invention, an extra therapeutic effect is exerted on the protective factor promoting action peculiar to the stomachic and the mucosal repair agent and the aggressive factor suppressing action peculiar to the analgesic / spasmodic.

This effect can be confirmed from the results of the following clinical tests. The pill of the present invention containing 1.2 g of psyllium as a daily dose, 0.3 g of carrot, 0.6 g of liquorice and 0.6 g of peonies as A, and 1.2 g of psyllium as a daily dose,
Control pills containing 0.3 g of carrots and 0.6 g of liquorice
And These pills were administered to those who had acute and chronic gastroenteritis as the main cases and also had other cases such as gastric ulcer and duodenal ulcer. The administration was carried out by a method of taking 30 tablets at a time three times a day between meals. The administration period was 14 days in each case. The administration was performed by a double-blind method.

At this time, the subjective symptoms in each case such as leaning of the stomach and fullness of the stomach or abdomen (included in discomfort of the stomach or abdomen) are defined as intensity, moderate, mild and no symptoms.
Table 1 below shows the number of cases of improvement in each case, from those who improved from severe symptoms to no symptoms, together with the rate of improvement.

[Table 1]

[0014] Table 2 shows the number of cases and the rate of improvement under the same conditions as above in the case of subjective symptoms for all cases.

[Table 2]

[0015] From these results, according to the present invention, compared to the control drug, according to the present invention, the peony has a ameliorating effect on the stomach leaning and swelling of the stomach or abdomen, which are cases of efficacy of the stomachic. It can be confirmed that it is exerted by the attack factor suppressing action.

[0016]

Next, embodiments of the present invention will be described. 1200 mg of powdered oat powder, 300 mg of carrot powder, 600 mg of liquorice powder and 600 mg of peony powder, and also a binder and a disintegrant are mixed uniformly, and 1500 mg of a 4.0% aqueous solution of a nonionic surfactant is added as a binder solution. Mixed.

Next, this is granulated by a spherical round machine,
The granules were dried, and then sized using a sieving machine to a particle size of 4 mm or less in diameter to obtain a granulating agent.

Further, a coating agent, a coloring agent and a polishing agent were added to an about 4.0% aqueous solution of a nonionic surfactant, and the mixture was uniformly mixed to obtain a coating agent. This coating agent was sprayed on the above-mentioned granulating agent and subjected to a coating treatment to obtain a pill having one particle of about 4 mm in diameter and about 40 mg in weight.

This pill is administered 30 times at a time, 3 times a day, between meals, for 14 days, mainly for acute and chronic gastroenteritis, and for patients with concurrent gastric ulcer, duodenal ulcer, etc. After administration, the number of cases of improvement was investigated for various symptoms, and the results are shown in Table 3 below together with the rate of improvement.

[Table 3] The numerical unit in Table 3 is a person, and the number in parentheses is the number of withdrawals. “Improvement” includes prominent improvement, improvement and mild improvement. The improvement rate was based on the following equation.

(Equation 1)

From the results shown in Table 3, it can be confirmed that about 80 to 95% of all cases have improved within a short period of time.

At the evaluation time on the 7th and 14th days from the start of the administration, each of the symptoms listed in Table 3 was comprehensively evaluated based on the five-grade criteria of prominent improvement, improvement, mild improvement, invariability, and deterioration, and inability to judge. The results were evaluated and shown in the following Table 4 as the degree of overall improvement.

[Table 4] The unit in Table 4 is a person, and the number in parentheses is the number of withdrawal persons. The numerical values in the lower part of each column are cumulative percentages of the improvement rate in the order of prominent improvement, improvement, and slight improvement.

Since the period of taking the gastrointestinal drug is generally two weeks, the degree of improvement was confirmed on the 7th and 14th days after the administration. From the results shown in Table 4, it can be seen that the comprehensive symptom is sufficiently improved early (day 7) and that the improvement is further improved over time.

The safety of the drug was confirmed by the occurrence of side effects and a general blood test and a blood biochemical test.
These test results were comprehensively evaluated and judged by three-step evaluation, and the results are shown in Table 5 below as an overall degree of safety.

[Table 5]

From the results shown in Table 5, it can be seen that the administration of the present drug is good in safety with respect to side effects and the like and has no problem.

The usefulness of the product as a product was confirmed from the efficacy and safety of the agent. That is, the above-mentioned overall improvement and overall safety were comprehensively evaluated, and the usefulness as a product was evaluated in four stages, and the results are shown in Table 6 below.

[Table 6] In addition, the numerical unit in Table 6 is a person, and the numerical value in parentheses is cumulative% in order of extremely useful, useful, and somewhat useful.

From the results in Table 6, it can be seen that the present agent is useful for treating gastrointestinal diseases.

Table 7 below shows the evaluation of the usefulness according to the severity at the start of the administration.

[Table 7] The numerical unit in Table 7 is a person, and the numerical value in parentheses is the same as in Table 6.

From the results shown in Table 7, it is confirmed that the present invention is easily applied to patients with mild or moderate symptoms, and its usefulness is high.

[0029]

The present invention comprises the above-mentioned composition,
The following effects are exhibited. That is, the present invention relates to a gastrointestinal drug, which comprises a composition in which liquorice and peonies are blended with the stomach medicine components of oats and carrots. For abdominal pain, discomfort in the stomach and abdomen, etc., an additive effect is exhibited.

Therefore, according to the gastrointestinal drug of the present invention, it is possible to exert its additional medicinal effect from the active stage of the disease relating to the gastrointestinal tract to the repair or scar stage. Therefore, it can be applied and improved over the entire symptom.

In addition, the gastrointestinal drug of the present invention has high safety, no side effects are observed, and its usefulness is high as described above. Although it does not conform to the principle of the above, it should be approved for production as a gastrointestinal drug.

Claims (1)

(57) [Claims] (1) A gastrointestinal drug which comprises psyllium, carrot, liquorice and peonies as essential components .