Novel matrix formula and production method of bisacodyl suppository

A technology of sacodyl suppository and bisacodyl, which is applied in the field of medicine to achieve the effect of improving stability

Inactive Publication Date: 2015-05-20
药大制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Aiming at the problems existing in the prior art, the present invention provides a new matrix and preparation method of bisacodyl suppository, which solves the problem of further improving the quality stability of bisacodyl suppository

Method used

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  • Novel matrix formula and production method of bisacodyl suppository

Examples

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Comparison scheme
Effect test

Embodiment 1

[0016] Example 1: Through the comparative investigation of the stability of the oily base of the present invention and the commercially available water-soluble base stored for 0, 6, and 12 months, it was found that the product using the oily base of the present invention has no unidentified spots.

Embodiment 2

[0017] Embodiment 2: Bisacodyl suppository preparation prescription composition and preparation method.

[0018] Bisacodyl 0.01g*1000 grains=10g;

[0019] Mixed fatty acid glycerides 1.49g*1000 grains=1490g;

[0020] Weigh 1490g of mixed fatty acid glycerides and melt in a water bath at 50-85°C;

[0021] Add the prescribed amount of bisacodyl;

[0022] Heat and stir in a water bath at 50-85°C for 1-5 hours to mix the main ingredients evenly;

[0023] Filling at 40-50°C.

example 3

[0024] Example 3: Bisacodyl suppository preparation prescription composition and preparation method.

[0025] Bisacodyl: 0.01g*1000 grains=10g

[0026] Stearic ester: 0.99g*1000 grains=990g

[0027] Weigh 990g of stearate and melt in a water bath at 50-85°C;

[0028] Add the prescribed amount of bisacodyl;

[0029] Heat and stir in a water bath at 50-85°C for 1-5 hours to mix the main ingredients evenly;

[0030] Filling at 40-50°C.

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Abstract

The invention relates to a novel matrix formula and a production method of a bisacodyl suppository, and belongs to the technical field of medicine. According to the novel matrix formula, a greasy matrix is adopted as an accessory and the matrix is mainly formed by use of semisynthetic fatty glycerides. The preparation method of the bisacodyl suppository comprises the following steps: weighing the matrix in a proportion specified in the formula, heating in water bath for melting, and then adding the bisacodyl in a proportion specified in the formula, heating in water bath and stirring for dissolving, and then filling. The matrix of the bisacodyl suppository is used for solving the problem that the existing commercial bisacodyl products in China are possible to cause adverse effects such as stomachache and intolerance to many patients. The stability of the quality of the bisacodyl suppository is greatly improved. The chromatogram of the product utilizing the greasy matrix has no unknown impurity peak.

Description

technical field [0001] The invention relates to a new matrix prescription and preparation method of bisacodyl suppository, belonging to the technical field of medicine. Background technique [0002] Bisacodyl is a contact laxative that acts directly on the large intestine, stimulating its sensory nerve endings, causing increased rectal reflex peristalsis, leading to defecation. It is clinically used for acute and chronic constipation and habitual constipation. Bisacodyl has been included in the pharmacopoeias of the United States, Europe and Japan, and has definite clinical curative effect. [0003] Currently, bisacodyl products on the domestic market include enteric-coated tablets and suppositories. Enteric-coated tablets are oral dosage forms, which have adverse reactions such as abdominal pain, and many patients cannot tolerate them. The suppository dosage form for external use is administered rectally, without adverse reactions of abdominal pain, and is more convenient ...

Claims

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Application Information

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IPC IPC(8): A61K47/44A61K47/14A61K31/4402A61K9/20A61K9/48A61P1/10G01N30/02
Inventor沈立郝静梅韩怡鲁曼曼
Owner药大制药有限公司