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Ilaprazole sodium composition serving as medicine for treating digestive diseases

A technology for ilaprazole sodium and digestive diseases, applied in the field of medicine, can solve the problems of low insoluble particles, low impurity content, and difficulty in hygroscopicity, and achieve the effects of low impurity content, high purity, and difficulty in hygroscopicity.

Inactive Publication Date: 2015-11-11
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 Compound crystal, after testing, it was surprisingly found 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. And high bioavailability, 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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  • Ilaprazole sodium composition serving as medicine for treating digestive diseases
  • Ilaprazole sodium composition serving as medicine for treating digestive diseases
  • Ilaprazole sodium composition serving as medicine for treating digestive diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1: Preparation of ilaprazole sodium crystals

[0028] (1) Prepare ethanol and N,N-dimethylformamide as a mixed solvent, and the volume ratio of ethanol and N,N-dimethylformamide is 2:1;

[0029] (2) Take the ilaprazole sodium raw material, dissolve it in the mixed solvent of ethanol and N,N-dimethylformamide whose volume is 6 times the weight of ilaprazole sodium in step (1), and heat up to 35 ℃, stirred until all dissolved to obtain ilaprazole sodium solution;

[0030] (3) Under the condition of a stirring speed of 560r / min, add the ilaprazole sodium solution in step (2) into isoamyl alcohol whose volume is 5 times the weight of ilaprazole sodium, and mix to form a suspension , cooling down to -10°C at a rate of 10°C / min;

[0031] (4) Perform suction filtration, wash the filter cake, and then vacuum-dry the filter cake to obtain a crystalline powder, which is the ilaprazole sodium compound.

[0032] The X-ray powder diffraction pattern that the prepared il...

Embodiment 2

[0033] Example 2: The preparation of ilaprazole sodium composition

[0034]The composition is: 1 part by weight of ilaprazole sodium crystal prepared by the present invention, and 0.003 part by weight of sodium dihydrogen phosphate.

[0035] The preparation method is:

[0036] (1) Weigh ilaprazole sodium crystals and sodium dihydrogen phosphate in proportion, and mix them thoroughly;

[0037] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0038] Example 3: The preparation of ilaprazole sodium composition

[0039] The composition is: 1 part by weight of ilaprazole sodium crystal prepared by the present invention, and 0.004 part by weight of sodium dihydrogen phosphate.

[0040] The preparation method is:

[0041] (1) Weigh ilaprazole sodium crystals and sodium dihydrogen phosphate in proportion, and mix them thoroughly;

[0042] (2) Dispense into sterilized vials and stopper them.

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Abstract

The invention discloses an ilaprazole sodium composition serving as medicine for treating digestive diseases, and belongs to the technical field of medicine. The composition is composed of ilaprazole sodium and sodium dihydrogen phosphate. The ilaprazole sodium is crystals, and the X-ray powder diffraction pattern measured through Cu-Kalpha rays is shown as figure 1. According to the ilaprazole sodium composition, the novel crystal form of the ilaprazole sodium is different from the crystal form structure in the prior art; due to experimental verification, it is found that the novel-crystal-form compound is high in purity, good in fluidity and stability, low in impurity content, not prone to absorbing moisture and safe and reliable in clinical application; powder-injections prepared through the novel-crystal-form compound are high in effect and bioavailability and good in stability; after the powder-injections are mixed with solvents, stability is good, the content of insoluble particles is quite small, and the powder-injections are quite suitable for clinical application.

Description

Technical field [0001] The invention is a pharmaceutical technology field, which involves a drug sodium composition for the treatment of digestive diseases. Background technique [0002] Epitzole, also known as IY-81149, is an irreversible new proton pump inhibitor developed by Yayang Pharmaceutical Company in South Korea.For the 1 / 4 of Omeprazole, it is not easy to produce resistance, and the toxic side effects are not obvious; compared with the original similar products, Epitrazole has overcome the original similar products to cause gastric empty delay to delay gastric empty latency to varying degrees., Swelling of wall cells and obvious defects in gastric acid secretion after drug discontinuation. At the same time, it can enhance the curative effect of dysfunctional dysfunctional dysfunction (GerD) and other acid -related diseases.Better, T1 / 2 is longer, can continue to suppress acid and control night acid secretion; its relying on CYP2C19 is small, and the enzyme gene is less...

Claims

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Application Information

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