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Pharmaceutical ilaprazole sodium composition for treating gastric ulcer

A technology of ilaprazole sodium and its composition, which is applied in the field of ilaprazole sodium composition for treating gastric ulcers, can solve the problems of low impurity content, poor stability, and difficulty in absorbing moisture, and achieve low impurity content and stable Good, not easy to absorb moisture

Inactive Publication Date: 2015-12-16
QINGDAO HUAZHICAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] But above-mentioned crystal form still has the problems such as lower drug effect, poorer stability etc., the inventor starts with researching on the existence state of ilaprazole sodium solid chemical substance, has prepared a kind of ilaprazole sodium through a large number of tests It is found through experiments that the new crystal compound has high purity, good fluidity, good stability, low impurity content, and is not easy to absorb moisture. It is safe and reliable in clinical application. High utilization, good stability, good stability after compatibility with solvents, very low content of insoluble particles, very suitable for clinical application

Method used

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  • Pharmaceutical ilaprazole sodium composition for treating gastric ulcer
  • Pharmaceutical ilaprazole sodium composition for treating gastric ulcer
  • Pharmaceutical ilaprazole sodium composition for treating gastric ulcer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1: Preparation of ilaprazole sodium crystals

[0024] Prepare the saturated butanol solution of ilaprazole sodium crude product, then add chloroform whose volume is 8 times the volume of the saturated butanol solution, stir evenly, stir while cooling, the cooling rate is 8 ° C / hour, and the stirring speed is 125 rpm, while adding chloroform with a volume twice the volume of chloroform, cooling to -5°C, stopping stirring, standing still for crystal growth for 4 hours, filtering, and drying under reduced pressure to obtain ilaprazole sodium crystalline compound.

[0025] The X-ray powder diffraction pattern that the prepared ilaprazole sodium crystal uses Cu-Kα ray to measure is as follows figure 1 shown.

Embodiment 2

[0026] Example 2: The preparation of ilaprazole sodium composition

[0027] The composition is: 1 part by weight of ilaprazole sodium crystal prepared by the present invention, and 0.001 part by weight of arginine.

[0028] The preparation method is:

[0029] (1) Weigh ilaprazole sodium crystals and arginine in proportion and mix them thoroughly;

[0030] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0031] Example 3: The preparation of ilaprazole sodium composition

[0032] The composition is: 1 part by weight of ilaprazole sodium crystal prepared by the present invention, and 0.002 part by weight of arginine.

[0033] The preparation method is:

[0034] (1) Weigh ilaprazole sodium crystals and arginine in proportion and mix them thoroughly;

[0035] (2) Dispense into sterilized vials and stopper them.

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Abstract

The invention discloses a pharmaceutical ilaprazole sodium composition for treating gastric ulcer and belongs to the technical field of medicines. The pharmaceutical ilaprazole sodium composition is prepared from ilaprazole sodium and arginine, wherein the ilaprazole sodium is a crystal, as shown in Figure 1 of an X-ray powder diffraction diagram obtained through Cu-KAlpha ray measurement. The novel crystal-form ilaprazole sodium is different from a crystal-form structure in the prior art. It is found that the novel crystal-form compound is high in purity, good in liquidity and stability, low in impurity content and is safe and reliable in clinic application and does not easily absorb moisture though test verification. The injection powder prepared by utilizing the novel crystal-form compound is high in medicinal effect and bioavailability and good in stability, has good stability after being compatible with a solvent, is very low in insoluble particle content and is very suitable for clinic application.

Description

technical field [0001] The invention belongs to the technical field of medicines, and relates to a drug ilaprazole sodium composition for treating gastric ulcer. Background technique [0002] Ilaprazole, also known as IY-81149, is a new type of irreversible proton pump inhibitor developed by Ilyang Pharmaceutical Company in Korea. Its inhibitory effect on Helicobacter pylori (HP) is stronger than that of omeprazole. It is 1 / 4 of omeprazole, less likely to produce drug resistance, and has no obvious toxic and side effects; compared with the original similar products, ilaprazole has overcome the delay in gastric emptying caused by the original similar products to varying degrees , parietal cell swelling and obvious rebound of gastric acid secretion after drug withdrawal, etc., and can enhance the curative effect on dysmotility-like functional dyspepsia (GERD) and other acid-related diseases, and the onset is faster and the acid-suppressing effect Better, longer t1 / 2, can sust...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61P1/04C07D401/14A61K31/198
Inventor 徐强
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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