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Capsule for treating ulcerative colitis

A capsule and ulcerative technology, applied in the field of capsules for the treatment of ulcerative colitis, can solve problems such as increased absorption, side effects, and the onset of pulmonary hypertension

Pending Publication Date: 2020-10-30
KEIO UNIV +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

On the other hand, aryl hydrocarbon receptors (AhR) also exist in the small intestine. According to the records of these documents, it can be predicted that when indole compounds such as IN or indigo and isoindigo come into contact with the small intestine, the aryl hydrocarbon receptors (AhR) AhR), it may produce side effects as described in Non-Patent Document 2.
[0010] Therefore, when a preparation containing an indole compound such as indigo is developed, as described in the above-mentioned literature, the absorption in the small intestine increases by contact with the small intestine, which may become a cause of pulmonary hypertension.

Method used

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  • Capsule for treating ulcerative colitis
  • Capsule for treating ulcerative colitis
  • Capsule for treating ulcerative colitis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0104] 5 capsules (corresponding to 0.5 mg of indigo) and 15 capsules (corresponding to 1.5 mg of indigo) of the above-mentioned indigo-blended capsule A were orally administered to 5 enteritis mouse samples (検body) for 7 days. It should be noted that in order to maintain the enteritis state of the mice for 7 days, the above-mentioned 2.0% DDS (dextran sulfate sodium salt) solution was also orally administered when the capsule A was orally administered.

[0105] Evaluation results

[0106] Regarding the enteritis inhibitory effect of indigo, according to the reduction of body weight (BW), enteritis activity score (Disease Activity Index Score (Disease Activity Index Score, DAI) score: the frequency of defecation, bloody stool, mucosal findings, overall Each item of the evaluation was scored on a scale of 4 from 0 to 3, and the total score (0 to 12)) and intestinal length (colon length, colon length) were evaluated. As the condition of colitis progressed, body weight decreased...

Embodiment 2

[0120] In order to cope with the high pH caused by hypochlorhydria, the indigo-blended capsule A of Preparation Example 1 was subjected to an acid treatment before drying to produce a capsule, and a disintegration test was performed.

[0121] Capsules containing indigo dipped in an acidic solution for 3 minutes or longer were prepared, and dipped for 60 minutes at 37° C. for 60 minutes at pH 4.0, which is the pH in the hypothetical mouse stomach, to conduct a disintegration test. After 60 minutes, the capsule was taken out into a glass container (Schale), and a photograph was taken to confirm the state of the capsule. Disintegration of the capsule and outflow of indigo in the capsule were not observed.

Embodiment 3

[0123] The following indigo-blend capsules B were prepared in the same manner as the indigo-blend capsules A of Preparation Example 1.

[0124] (a) Content solution: Disperse 8.33 g of indigo (manufactured by Tokyo Chemical Industry Co., Ltd., purity: 97%) in 85.67 g of melted oily substance (glycerin fatty acid ester) at 32°C, 3.00 lecithin and 3.00 tocopherol In the melting liquid, the obtained solution was used as the content liquid.

[0125] (b) Protective layer solution: Same as indigo-blended capsule A.

[0126] (c) Film solution: same as indigo-blended capsule A.

[0127] In order to confirm the improvement of the adhesion to the large intestine, an in vitro test was carried out using the following two virtual plates of large intestine cells (both manufactured by Corning International Co., Ltd.).

[0128] (1) BioCoat TM Fibronectin 6-well plate (BioCoat TM Fibronectin 6・well plate) (coating ingredient: fibronectin)

[0129] (2) BioCoat TM Poly / D / Lysine / Laminin 6-...

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Abstract

The purpose of the present invention is to obtain an indigo-containing capsule for treating ulcerative colitis, when orally administered, said capsule being more efficacious against ulcerative colitisand having less hepatotoxicity as a side effect compared to conventional products. The present invention pertains to a capsule for treating ulcerative colitis, said capsule comprising a drug-containing content, a protective layer coating the content and a film formed outside the protective layer, which are arranged in a concentric pattern, wherein: the content is a dispersion or solution of indigo which is a drug for treating ulcerative colitis; and the film is a colon-disintegrating film which disintegrates locally in the large intestine.

Description

technical field [0001] The present invention relates to a capsule for treating ulcerative colitis (colitis), in particular, relates to a capsule for treating ulcerative colitis which is not easily disintegrated in the stomach or small intestine when administered orally , and disintegrate in the large intestine so that indigo, a drug for treating ulcerative colitis, can directly reach the large intestine and play a role. Background technique [0002] Qingdai is a crude drug extracted from plants containing indigo, and is mainly used as a dye for indigo dyeing. In China, traditional Chinese medicines containing Qingdai have been used for ulcerative colitis since ancient times, but sufficient scientific verification has not been carried out. [0003] In Gastroenterology: Inpress "Efficacy of Indigo naturalis in a Multicenter Randomized Controlled Trial of Patients with Ulcerative Colitis", Makoto Naganuma et al., online November 22, 2017 In the publication (Non-Patent Documen...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/404A61K9/52A61K47/14A61K47/36A61K47/42A61P1/04
CPCA61K31/404A61P1/04A61K9/4816A61K9/4825A61K9/4866A61K9/4875A61K9/4891A61K47/36
Inventor 金井隆典西村秀雄小山智之足立卓彦早川博之
Owner KEIO UNIV
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